Company ยท US
Pcl-Ria, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1983. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| JIT | Calibrator, Secondary | 2 |
| CGI | Radioimmunoassay, Estriol | 1 |
| DKA | Antiserum, Digoxin | 1 |
| DMP | Digoxin Control Serum, Ria | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 |
| JIS | Calibrator, Primary | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KTS | Second Antibody (Species Specific Anti-Animal Gamma Globulin) | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 1983 | K830526 | B-GCG SYSTEM BY RIA Pcl-Ria, Inc. | JHI |
| Nov 1, 1982 | K823014 | DIGOXIN KIT Pcl-Ria, Inc. | DPB |
| Nov 1, 1982 | K822935 | THYROID STIMULATING HORMONE Pcl-Ria, Inc. | JLW |
| Sep 30, 1982 | K822612 | T3 UPTAKE KITS Pcl-Ria, Inc. | KHQ |
| Apr 16, 1982 | K820886 | THYROXINE T4 KIT Pcl-Ria, Inc. | CDX |
| Mar 26, 1982 | K820358 | FOLLICLE STIMULATING HORMONE KIT Pcl-Ria, Inc. | CGJ |
| Mar 25, 1982 | K820357 | LUTEINIZING HORMONE KIT Pcl-Ria, Inc. | CEP |
| Oct 2, 1981 | K812666 | THYROXINE (T4) 125I Pcl-Ria, Inc. | CDP |
| Apr 14, 1981 | K810867 | FOLLICLE STIMULATING HORMONE (FSH) Pcl-Ria, Inc. | JIS |
| Apr 8, 1981 | K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM Pcl-Ria, Inc. | CGJ |
| Mar 31, 1981 | K810754 | LUTENIZING HORMONES Pcl-Ria, Inc. | CEP |
| Mar 31, 1981 | K810741 | LUTEINIZING HORMONE Pcl-Ria, Inc. | CEP |
| Jan 9, 1981 | K803180 | 1-125 LABELED TRIIODOTHYRONINE(T3) Pcl-Ria, Inc. | CDP |
| Dec 22, 1980 | K803047 | I-125 LABELED DIGOXIN Pcl-Ria, Inc. | LCS |
| Jul 17, 1979 | K790876 | LABELED HUMAN CHORIONIC GONADOTROPHIN Pcl-Ria, Inc. | JHI |
| Jul 17, 1979 | K790864 | RABBIT ANTISERUM TO HUMAN CHORIONIC Pcl-Ria, Inc. | JHI |
| Jul 17, 1979 | K790863 | HUMAN CHORIONIC GONADOTROPHIN STANDARDS Pcl-Ria, Inc. | JHI |
| Aug 31, 1978 | K781284 | RABBIT ANTIBODY TO HUMAN T3 Pcl-Ria, Inc. | CDP |
| Aug 14, 1978 | K781071 | STANDARDS, HORMONE, THYROID STIMULATING Pcl-Ria, Inc. | JIT |
| Aug 14, 1978 | K781069 | T3 STANDARDS IN HUMAN SERUM Pcl-Ria, Inc. | JIT |
| Aug 14, 1978 | K780889 | DIGOXIN STANDARDS IN HUMAN SERUM Pcl-Ria, Inc. | DMP |
| Aug 10, 1978 | K781070 | SECOND ANTIBODY Pcl-Ria, Inc. | KTS |
| May 19, 1978 | K780576 | 125-I LABELED HUMAN LUTEINIZING HORMONE Pcl-Ria, Inc. | CEP |
| Mar 17, 1978 | K780316 | RABBIT ANTIBODY TO DIGOXIN Pcl-Ria, Inc. | DKA |
| Feb 13, 1978 | K780059 | RABBIT ANTIBODY/THYROID STIMUL. HORMONE Pcl-Ria, Inc. | JLW |
| Feb 13, 1978 | K780050 | THYROXINE STDS. IN HUMAN SERUM Pcl-Ria, Inc. | CDX |
| Feb 7, 1978 | K780015 | THYROID STIMULATING HORMONE Pcl-Ria, Inc. | JLW |
| Feb 3, 1978 | K780016 | HUMAN FOLLICLE STIMULATING HORMONE Pcl-Ria, Inc. | CGI |
| Nov 22, 1977 | K772096 | IN VITRO DIAGNOSTIC REAGENT Pcl-Ria, Inc. | CDX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||