CK-ISOZYME U.V. REAGENT SET— 510(k) K823550
Substantially EquivalentGelman Sciences, Inc.
FDA 510(k) clearance K823550 for CK-ISOZYME U.V. REAGENT SET, Substantially Equivalent on 1983-01-07. Applicant: Gelman Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Gelman Sciences, Inc.
- Product code
- Code JHT
- 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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More clearances from Gelman Sciences, Inc.
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