MICROSOMAL EIA TEST KIT
FDA 510(k) clearance K951364 · decided 1995-11-20
Clearance details
- K-number
- K951364
- Device name
- MICROSOMAL EIA TEST KIT
- Applicant
- Immunoprobe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-24
- Decision date
- 1995-11-20
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- JNL
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Washington, D.C., DC, 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 |
|---|---|---|
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| Access Thyroglobulin Antibody II (K240996) | Beckman Coulter, Inc. | 2024-07-03 |
| ACCESS THYROGLOBULIN ANITBODY (K112933) | Beckman Coulter, Inc. | 2011-12-27 |
| IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661) | Phadia US, Inc. | 2007-11-20 |
| ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |
| ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834) | Monobind | 1997-07-03 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451) | Hycor Biomedical, Inc. | 1996-11-25 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341) | Hycor Biomedical, Inc. | 1996-11-25 |
| ANTI-TPO (K954256) | Biomerica, Inc. | 1995-11-27 |
| THYROGLOBULIN EIA TEST KIT (K951362) | Immunoprobe, Inc. | 1995-11-20 |
| AURAFLEX TG-AB AND TPO-AB (K951320) | Organon Teknika Corp. | 1995-08-25 |
| AURAFLEX TPO-AB (K952607) | Organon Teknika Corp. | 1995-08-25 |
Recalls involving this device
No recalls on record reference this clearance.