SERA-TEK THYROGLOBULIN ANTIBODY TEST
FDA 510(k) clearance K865020 · decided 1987-02-02
Clearance details
- K-number
- K865020
- Device name
- SERA-TEK THYROGLOBULIN ANTIBODY TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-23
- Decision date
- 1987-02-02
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- DDC
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SERAQUEST ANTI-THYROGLOBULIN (K023592) | Quest Intl., Inc. | 2003-01-06 |
| ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208) | Beckman Coulter, Inc. | 2001-09-07 |
| MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K000363) | Zeus Scientific, Inc. | 2000-02-18 |
| ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (K991610) | Zeus Scientific, Inc. | 1999-06-25 |
| ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K991179) | Zeus Scientific, Inc. | 1999-06-17 |
| ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (K971835) | Monobind | 1997-07-03 |
| SERODIA ATG (K953066) | Fujirebio America, Inc. | 1995-08-14 |
| AUTOSTAT II ANTI-THYROGLOBULIN (K943625) | Cogent Diagnotics , Ltd. | 1994-12-22 |
| THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (K936010) | Biomerica, Inc. | 1994-07-18 |
| QUANTA LITE(TM) THYROID T ELISA (K930486) | Inova Diagnostics, Inc. | 1993-03-15 |
| THYMUNE-M (K780873) | Burroughs Wellcome Co. | 1978-06-14 |
| THYMUNE-T (K780874) | Burroughs Wellcome Co. | 1978-06-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |