CREATINE KINASE MB DETERMINATION (UV)
FDA 510(k) clearance K942958 · decided 1994-11-21
Clearance details
- K-number
- K942958
- Device name
- CREATINE KINASE MB DETERMINATION (UV)
- Applicant
- Biochemical Trade, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-23
- Decision date
- 1994-11-21
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- JHW
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7 recall (Z-2649-2017) | Medtest Holdings, Inc. | 2017-06-29 |