QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)— 510(k) K791723
Substantially EquivalentOrganon, Inc.
FDA 510(k) clearance K791723 for QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN), Substantially Equivalent on 1979-10-01. Applicant: Organon, Inc.. Device class: 1.
Clearance details
- Applicant
- Organon, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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