IMMUNODOT THYROID AUTOIMMUNITY PANEL
FDA 510(k) clearance K903843 · decided 1990-10-02
Clearance details
- K-number
- K903843
- Device name
- IMMUNODOT THYROID AUTOIMMUNITY PANEL
- Applicant
- General Biometrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-21
- Decision date
- 1990-10-02
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JNL
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| MICROSOMAL EIA TEST KIT (K951364) | Immunoprobe, Inc. | 1995-11-20 |
| AURAFLEX TG-AB AND TPO-AB (K951320) | Organon Teknika Corp. | 1995-08-25 |
Recalls involving this device
No recalls on record reference this clearance.