FDA Product Code
FDA Product Code CDX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1700
510(k) Clearances — 121 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K772064 | THYRODOT-4 ANTISERA LYOPHOLIZED | Medcom Diagnostics, Inc. | 1977-11-14 | Traditional | PDF ↗ |
| K772014 | AMES T-4 STRIP TEST | Miles Laboratories, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771414 | T4 BY RIA DIAG. KIT | Biomedical Labs., Inc. | 1977-09-22 | Traditional | PDF ↗ |
| K771606 | IMMUNOSPOT NEONATAL T4 TEST | Meloy Laboratories, Inc. | 1977-09-15 | Traditional | PDF ↗ |
| K771221 | T4 RIA TEST SYSTEM | Monobind | 1977-08-04 | Traditional | PDF ↗ |
| K771309 | RIA FOR TOTAL THYROXINE | Abbott Laboratories | 1977-08-03 | Traditional | PDF ↗ |
| K771135 | QUANTIMUNE NEONATAL & THYROXINE RIA | Bio-Rad | 1977-07-14 | Traditional | PDF ↗ |
| K770733 | REAGENT SYSTEM, THYROXINE, ARIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 | Traditional | PDF ↗ |
| K770737 | REAGENT SET, T-4, CPB | G.D. Searle and Co. | 1977-06-22 | Traditional | PDF ↗ |
| K770940 | TOTAL THYROXINE (RIA) REAGENT SET | The Dow Chemical Co. | 1977-06-22 | Traditional | PDF ↗ |
| K770676 | T-4 RIA REAGENT SET | G.D. Searle and Co. | 1977-05-20 | Traditional | PDF ↗ |
| K770726 | RIA KIT, T4 CLASP | Squibb & Sons, Inc. | 1977-04-28 | Traditional | PDF ↗ |
| K770474 | THYROSCREEN TM T4 DIAGNOSTIC KIT | Abbott Laboratories | 1977-04-28 | Traditional | PDF ↗ |
| K761272 | CENTRIA T4 RIA | Clinical Diagnostics, Inc. | 1977-03-16 | Traditional | PDF ↗ |
| K770241 | NEONATAL T4 RIA KIT | Diagnostic Products Corp. | 1977-02-14 | Traditional | PDF ↗ |
| K770156 | SPAC TM T4 RIA KIT | Mallinckrodt Critical Care | 1977-02-07 | Traditional | PDF ↗ |
| K761282 | DATA-TOPE T4 RIA PROCEDURE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 | Traditional | PDF ↗ |
| K760572 | SERALUTE | Miles Laboratories, Inc. | 1976-11-23 | Traditional | PDF ↗ |
| K760227 | RADIOIMMUNOASSAY | Kallestad Laboratories, Inc. | 1976-07-26 | Traditional | PDF ↗ |
| K760079 | REAGENT, THYROXINE T4 (#210) | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
| K760135 | TEST, RA, QUANTA-COUNT T-4 | Bio-Rad | 1976-07-20 | Traditional | PDF ↗ |
Product code CDX · Class II · Clinical Chemistry. Data: openFDA.