Company ยท US
Clinical Assays, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1983. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 3 |
| CDD | Radioassay, Vitamin B12 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| CGC | Radioimmunoassay, Gastrin | 1 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| DKP | Radioimmunoassay, Phenobarbital | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 1983 | K832712 | FOLATE RADIOASSAY KIT CA-1562-125 Clinical Assays, Inc. | CGN |
| Oct 4, 1983 | K832711 | VITAMIN B12 FOLATE CA-1515-125 Clinical Assays, Inc. | CDD |
| Oct 4, 1983 | K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 Clinical Assays, Inc. | CDD |
| Dec 28, 1982 | K823476 | GAMMADAB LH RADIO-KIT #CA-1508 Clinical Assays, Inc. | CEP |
| Dec 22, 1982 | K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST Clinical Assays, Inc. | JHI |
| Jun 24, 1982 | K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT Clinical Assays, Inc. | CGJ |
| Jun 22, 1982 | K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT Clinical Assays, Inc. | DGC |
| Sep 24, 1981 | K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY Clinical Assays, Inc. | CFP |
| May 27, 1981 | K810722 | GASTRIN RADIOIMMUNOASSAY TEST Clinical Assays, Inc. | CGC |
| Apr 23, 1981 | K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST Clinical Assays, Inc. | CEE |
| Oct 23, 1980 | K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY Clinical Assays, Inc. | GOL |
| Dec 4, 1979 | K791497 | PROSTATIC ACID RADIOIMMUNOASSAY TEST Clinical Assays, Inc. | JFH |
| Jul 17, 1979 | K791079 | GAMMADAB (125 1) FOLATE RADIOASSAY KIT Clinical Assays, Inc. | CGN |
| Jan 26, 1979 | K782109 | RIA KIT, GAMMACOAT Clinical Assays, Inc. | CDX |
| Jan 10, 1979 | K781938 | RIA KIT, GAMMADAB ESTRIOL Clinical Assays, Inc. | CGI |
| Aug 14, 1978 | K781235 | IV VITRO GAMMADAB T4 RIA KIT Clinical Assays, Inc. | CDX |
| Aug 14, 1978 | K780934 | IN VITRO TOBRAMYCIN RIA KIT Clinical Assays, Inc. | KLB |
| Jul 27, 1978 | K780854 | IN VITRO NEONATAL T4 Clinical Assays, Inc. | CDX |
| May 12, 1978 | K780709 | IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST Clinical Assays, Inc. | |
| Mar 27, 1978 | K772017 | IN VITRO THEOPHYLLINE RIA TEST Clinical Assays, Inc. | KLS |
| Dec 6, 1977 | K772109 | IN VITRO HUMAN TSH RIA TEST Clinical Assays, Inc. | JLW |
| Nov 28, 1977 | K772111 | IN VITRO PHENOBARBITAL RIA TEST Clinical Assays, Inc. | DKP |
| Nov 22, 1977 | K772110 | IN VITRO DIGOXIN RIA TEST Clinical Assays, Inc. | DNL |
| Nov 17, 1977 | K772108 | IN VITRO T3 RIA TEST Clinical Assays, Inc. | CDP |
| Sep 13, 1977 | K771597 | IN VITRO FOLATE RADIOASSAY KIT Clinical Assays, Inc. | CGN |
| Jun 17, 1977 | K770702 | IN VITRO FERRITIN RIA TEST Clinical Assays, Inc. | DBF |
| Apr 6, 1977 | K770480 | IN VITRO T-3 UPTAKE TEST Clinical Assays, Inc. | KHQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||