American Monitor Corp.: FDA filings under this applicant name
FDA lists 73 510(k) clearances under the applicant name “American Monitor Corp.” (first 1977, latest 1990), across 41 product codes in 3 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 5 | 5 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 5 | 5 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 5 | 5 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
Plus 31 more product codes.
Review panels
- Clinical Chemistry (64)
- Clinical Toxicology (6)
- Microbiology (1)
Most recent American Monitor Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | CIT | 1990-01-11 | 90 |
| K895999 | PHOSPHORUS | CEO | 1990-01-11 | 90 |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | CKA | 1989-11-13 | 31 |
| K895423 | ACCESS CHEMISTRY ANALYZER | JJE | 1989-10-04 | 27 |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | JJE | 1989-08-10 | 107 |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | CDQ | 1989-06-20 | 76 |
| K893479 | CHOLESTEROL REAGENT SET | CHH | 1989-06-19 | 46 |
| K892002 | NEOCHROME(R) III GLUCOSE | CGA | 1989-06-12 | 76 |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | JQB | 1989-03-24 | 60 |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | JIY | 1989-02-03 | 30 |
63 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Monitor 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.
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 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)
- American Sterilizer Co. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Monitor Corp.?
FDA lists 73 510(k) clearances under the applicant name “American Monitor Corp.” (first 1977, latest 1990), across 41 product codes in 3 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 Monitor Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Monitor Corp. is 35 days.
Which FDA product codes appear under American Monitor Corp.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 5); CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 5); JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 5).
Next steps
- See all 73 American Monitor Corp. clearances with predicates and recalls
- Run predicate analysis for product code CHH, American Monitor 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, 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.