CREATINE KINASE REAGENT SYSTEM
FDA 510(k) clearance K952745 · decided 1995-08-11
Clearance details
- K-number
- K952745
- Device name
- CREATINE KINASE REAGENT SYSTEM
- Applicant
- Medical Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-16
- Decision date
- 1995-08-11
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ventura, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.