CPK(CK) IN VITRO DIAG. REAGENT SET— 510(k) K813406
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K813406 for CPK(CK) IN VITRO DIAG. REAGENT SET, Substantially Equivalent on 1981-12-22. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code JHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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