American Scientific Products: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “American Scientific Products” (first 1981, latest 1986), across 22 product codes in 5 review panels. Median 510(k) review time under this name: 30 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 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| GIE | Fibrometer | 2 | 2 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 2 | 2 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 2 | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 1 | 1 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 1 | 1 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 1 | 1 |
Plus 12 more product codes.
Review panels
- Microbiology (11)
- Clinical Chemistry (8)
- Pathology (4)
- Hematology (3)
- Immunology (1)
Most recent American Scientific Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | — | 1986-12-24 | 15 |
| K844042 | BLOOD DILUTION VIAL | GKL | 1984-10-23 | 6 |
| K831634 | GLUCOSE REAGENT B6360-11 | CGA | 1983-07-19 | 60 |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | CDQ | 1983-07-07 | 48 |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | CDQ | 1983-07-07 | 48 |
| K831628 | CREATININE REAGENTS B6370-13 | CGX | 1983-07-06 | 47 |
| K831627 | CREATININE REAGENTS B6360-10 | CGX | 1983-07-06 | 47 |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | CGA | 1983-07-06 | 47 |
| K831571 | ROTOR | JJG | 1983-06-30 | 45 |
| K831569 | REAGENT CUPS | JJG | 1983-06-30 | 45 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Scientific Products.
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.
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 Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Scientific Products?
FDA lists 28 510(k) clearances under the applicant name “American Scientific Products” (first 1981, latest 1986), across 22 product codes in 5 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 Scientific Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Scientific Products is 30 days.
Which FDA product codes appear under American Scientific Products?
The most frequent FDA product codes under this applicant name are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 2); CGA (Glucose Oxidase, Glucose, 2); CGX (Alkaline Picrate, Colorimetry, Creatinine, 2).
Next steps
- See all 28 American Scientific Products clearances with predicates and recalls
- Run predicate analysis for product code CDQ, American Scientific Products'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.