CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT— 510(k) K062503
Substantially EquivalentCatachem, Inc.
FDA 510(k) clearance K062503 for CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT, Substantially Equivalent on 2007-01-19. Applicant: Catachem, Inc.. Device class: 2.
Clearance details
- Applicant
- Catachem, Inc.
- Product code
- Code KWW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1177
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
Recent devices under product code KWW
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