American Diagnostic Corp.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “American Diagnostic Corp.” (first 1980, latest 2017), across 35 product codes in 7 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 175 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name American Diagnostic Corp. took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 3 | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Plus 25 more product codes.
Review panels
- Clinical Toxicology (15)
- Clinical Chemistry (11)
- Cardiovascular (5)
- Hematology (5)
- General Hospital (1)
- Immunology (1)
- Ophthalmic (1)
Most recent American Diagnostic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162589 | Adscope 658 Electronic Stethoscope | DQD | 2017-03-10 | 175 |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | HLJ | 2010-11-19 | 374 |
| K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | DQD | 2006-05-15 | 95 |
| K012304 | ADC 656 ELECTRONIC STETHOSCOPE | DQD | 2001-11-01 | 104 |
| K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | DXQ | 1997-01-27 | 203 |
| K940686 | ELECTRONIC THERMOMETERS | FLL | 1994-07-08 | 142 |
| K935944 | PROSCOPES AND ADSCOPES | LDE | 1994-03-03 | 80 |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | GIZ | 1993-10-18 | 167 |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | JIR | 1989-09-18 | 95 |
| K893608 | ACTICHROME ATIII KIT | JBQ | 1989-06-23 | 44 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Diagnostic Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under American Diagnostic Corp. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
- American Sterilizer Co. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Diagnostic Corp.?
FDA lists 39 510(k) clearances under the applicant name “American Diagnostic Corp.” (first 1980, latest 2017), across 35 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Diagnostic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Diagnostic Corp. is 34 days.
Which FDA product codes appear under American Diagnostic Corp.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 3); GGP (Test, Qualitative And Quantitative Factor Deficiency, 2); JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 2).
Next steps
- See all 39 American Diagnostic Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQD, American Diagnostic Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.