ACS FRT4 IMMUNOASSAY
FDA 510(k) clearance K961510 · decided 1996-06-17
Clearance details
- K-number
- K961510
- Device name
- ACS FRT4 IMMUNOASSAY
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-19
- Decision date
- 1996-06-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10 recall (Z-1970-2013) | Siemens Healthcare Diagnostics, Inc | 2013-08-14 |