CIBA CORNING ACS PROLACTIN IMMUNOASSAY
FDA 510(k) clearance K904714 · decided 1990-11-07
Clearance details
- K-number
- K904714
- Device name
- CIBA CORNING ACS PROLACTIN IMMUNOASSAY
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-18
- Decision date
- 1990-11-07
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- CFT
- Device class
- 1
- Regulation number
- 862.1625
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 recall (Z-2409-2012) | Siemens Healthcare Diagnostics, Inc | 2012-09-19 |
| ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or recall (Z-2410-2012) | Siemens Healthcare Diagnostics, Inc | 2012-09-19 |