CREATINE KINASE (CK)
FDA 510(k) clearance K972155 · decided 1997-07-17
Clearance details
- K-number
- K972155
- Device name
- CREATINE KINASE (CK)
- Applicant
- Stanbio Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1997-06-05
- Decision date
- 1997-07-17
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reag recall (Z-2650-2017) | Medtest Holdings, Inc. | 2017-06-29 |