FDA Product Code
FDA Product Code DDC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5870
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Quest Intl., Inc. | 2003-01-06 | Traditional | PDF ↗ |
| K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 | Beckman Coulter, Inc. | 2001-09-07 | Traditional | PDF ↗ |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2000-02-18 | Special | PDF ↗ |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-06-17 | Traditional | PDF ↗ |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Monobind | 1997-07-03 | Traditional | PDF ↗ |
| K953066 | SERODIA ATG | Fujirebio America, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1994-12-22 | Traditional | PDF ↗ |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Biomerica, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K930486 | QUANTA LITE(TM) THYROID T ELISA | Inova Diagnostics, Inc. | 1993-03-15 | Traditional | PDF ↗ |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | Miles Laboratories, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K780874 | THYMUNE-T | Burroughs Wellcome Co. | 1978-06-14 | Traditional | PDF ↗ |
| K780873 | THYMUNE-M | Burroughs Wellcome Co. | 1978-06-14 | Traditional | PDF ↗ |
Product code DDC · Class II · Immunology. Data: openFDA.