IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
FDA 510(k) clearance K872305 · decided 1987-07-01
Clearance details
- K-number
- K872305
- Device name
- IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-08
- Decision date
- 1987-07-01
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitativ recall (Z-0646-2013) | Siemens Healthcare Diagnostics | 2013-01-07 |
| Immunoradiometric assay. recall (Z-0647-2013) | Siemens Healthcare Diagnostics | 2013-01-07 |
| Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitativ recall (Z-0648-2013) | Siemens Healthcare Diagnostics | 2013-01-07 |