Nms Pharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Nms Pharmaceuticals, Inc.” (first 1984, latest 1987), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 109 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 | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| IAF | Wright'S Stain | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Hematology (1)
- Immunology (1)
- Pathology (1)
Most recent Nms Pharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861202 | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS | JJY | 1987-01-09 | 284 |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | IAF | 1986-10-10 | 354 |
| K860828 | FORETEL, COLOR OVULATION TEST | CEP | 1986-08-04 | 152 |
| K853925 | QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA | JHI | 1985-12-02 | 69 |
| K851445 | COLOR OVULATION TEST | CEP | 1985-07-29 | 109 |
| K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL | KHE | 1985-06-17 | 133 |
| K850786 | TOTAL HIGE ENZYME IMMUNOASSAY | DGC | 1985-04-12 | 45 |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | CGI | 1985-03-26 | 28 |
| K842499 | NMS 1043 ENZYME IMMUNOASSAY KIT | JHI | 1984-09-14 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Nms Pharmaceuticals, 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 Nms Pharmaceuticals, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Nms Pharmaceuticals, Inc.” (first 1984, latest 1987), across 7 product codes in 4 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 Nms Pharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nms Pharmaceuticals, Inc. is 109 days.
Which FDA product codes appear under Nms Pharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 2); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CGI (Radioimmunoassay, Estriol, 1).
Next steps
- See all 9 Nms Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Nms Pharmaceuticals, 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.