Endocrine-Metabolic Center: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Endocrine-Metabolic Center” (first 1979, latest 1982), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
Review panels
Most recent Endocrine-Metabolic Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821131 | RADIOIMMUNOASSAY PARATHYROID HORMONE MID | CEW | 1982-06-02 | 43 |
| K811993 | RADIOIMMUNOASSAY, FOLLICLE STIMULATING | CGJ | 1981-08-03 | 20 |
| K811994 | RADIOIMMUNOASSAY LUTEINIZING HORMONE | CEP | 1981-07-27 | 13 |
| K810948 | RADIOIMMUNOASSAY THYROID STIM. HORM. KIT | JLW | 1981-04-17 | 10 |
| K810351 | RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE | CDP | 1981-02-23 | 13 |
| K800188 | EMC-M-180, T3 UPTAKE - 100 TUBES | KHQ | 1980-02-13 | 15 |
| K800187 | EMC-M-175, THYROXINE - 100 TUBES | CDX | 1980-02-13 | 15 |
| K790602 | RIA, DIGNXIN-125-I | DPB | 1979-07-30 | 125 |
| K790630 | RIA, INSULIN, DOUBLE ANTIBODY | CFP | 1979-07-24 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Endocrine-Metabolic Center.
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 Endocrine-Metabolic Center?
FDA lists 9 510(k) clearances under the applicant name “Endocrine-Metabolic Center” (first 1979, latest 1982), across 9 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 Endocrine-Metabolic Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endocrine-Metabolic Center is 15 days.
Which FDA product codes appear under Endocrine-Metabolic Center?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDX (Radioimmunoassay, Total Thyroxine, 1); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 9 Endocrine-Metabolic Center clearances with predicates and recalls
- Run predicate analysis for product code CDP, Endocrine-Metabolic Center'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.