BIOLOGICAL INDICATOR - KEMMED & BIOSURE— 510(k) K802228
Substantially EquivalentKem Medical Products Corp.
FDA 510(k) clearance K802228 for BIOLOGICAL INDICATOR - KEMMED & BIOSURE, Substantially Equivalent on 1980-12-09. Applicant: Kem Medical Products Corp.. Device class: 2.
Clearance details
- Applicant
- Kem Medical Products Corp.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FRC
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