Pcl-Ria, Inc.: FDA clearances and approvals
Pcl-Ria, Inc. has 29 FDA 510(k) clearances (first 1977, latest 1983), across 15 product codes in 3 review panels. Median 510(k) review time: 34 days.
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 | 4 | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| DKA | Antiserum, Digoxin | 1 | 1 |
| DMP | Digoxin Control Serum, Ria | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (24)
- Clinical Toxicology (4)
- Immunology (1)
Most recent Pcl-Ria, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | JHI | 1983-04-05 | 47 |
| K823014 | DIGOXIN KIT | DPB | 1982-11-01 | 19 |
| K822935 | THYROID STIMULATING HORMONE | JLW | 1982-11-01 | 28 |
| K822612 | T3 UPTAKE KITS | KHQ | 1982-09-30 | 31 |
| K820886 | THYROXINE T4 KIT | CDX | 1982-04-16 | 17 |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | CGJ | 1982-03-26 | 45 |
| K820357 | LUTEINIZING HORMONE KIT | CEP | 1982-03-25 | 44 |
| K812666 | THYROXINE (T4) 125I | CDP | 1981-10-02 | 11 |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | JIS | 1981-04-14 | 14 |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | CGJ | 1981-04-08 | 9 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pcl-Ria, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pcl-Ria, Inc. have?
Pcl-Ria, Inc. has 29 FDA 510(k) clearances (first 1977, latest 1983), across 15 product codes in 3 review panels.
How long does FDA take to clear Pcl-Ria, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pcl-Ria, Inc.'s cleared 510(k)s is 34 days.
What devices does Pcl-Ria, Inc. make?
Its most frequent FDA product codes are CEP (Radioimmunoassay, Luteinizing Hormone, 4); JHI (Visual, Pregnancy Hcg, Prescription Use, 4); CDP (Radioimmunoassay, Total Triiodothyronine, 3).
Has Pcl-Ria, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pcl-Ria, Inc. Related entities may recall under other names.
Next steps
- See all 29 Pcl-Ria, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Pcl-Ria, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.