Microanalytic Research, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Microanalytic Research, Inc.” (first 1980, latest 1986), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 | 1 |
Review panels
Most recent Microanalytic Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861097 | TRYPSIN RIA KIT | JNO | 1986-05-29 | 66 |
| K820741 | MR1 LUTROPIN RIA KIT | CEP | 1982-04-14 | 27 |
| K820740 | MR1 FOLLITROPIN RIA KIT | CGJ | 1982-04-06 | 19 |
| K813516 | MRI TOBRAMYCIN RIA KIT | KLB | 1981-12-29 | 14 |
| K812394 | MRI GENTAMICIN RIA KIT | DJB | 1981-09-08 | 19 |
| K810949 | MRI PROLACTIN RIA KIT | CFT | 1981-07-10 | 94 |
| K802754 | IMMUNOREACTIVE ESTRIOL RIA KIT | CGI | 1981-01-21 | 79 |
| K801491 | MRI HCG-BETA RIA KIT CAT. #MR-10100 | JHI | 1980-08-13 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Microanalytic Research, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Microanalytic Research, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Microanalytic Research, Inc.” (first 1980, latest 1986), across 8 product codes in 2 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 Microanalytic Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microanalytic Research, Inc. is 38 days.
Which FDA product codes appear under Microanalytic Research, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 1); CFT (Radioimmunoassay, Prolactin (Lactogen), 1); CGI (Radioimmunoassay, Estriol, 1).
Next steps
- See all 8 Microanalytic Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Microanalytic Research, Inc.'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.