VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
FDA 510(k) clearance K973030 · decided 1997-09-04
Clearance details
- K-number
- K973030
- Device name
- VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-14
- Decision date
- 1997-09-04
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diag recall (Z-1337-2013) | Ortho-Clinical Diagnostics | 2013-05-17 |