CREATINE KINASE (CK) REAGENT SET
FDA 510(k) clearance K930660 · decided 1993-03-29
Clearance details
- K-number
- K930660
- Device name
- CREATINE KINASE (CK) REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1993-02-09
- Decision date
- 1993-03-29
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.