N-ASSAY TIA MICROALBUMIN CALIBRATOR SET— 510(k) K934143
Substantially EquivalentCrestat Diagnostics, Inc.
FDA 510(k) clearance K934143 for N-ASSAY TIA MICROALBUMIN CALIBRATOR SET, Substantially Equivalent on 1993-11-05. Applicant: Crestat Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Crestat Diagnostics, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake Village, CA, US
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