SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS— 510(k) K051432
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K051432 for SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS, Substantially Equivalent on 2005-06-17. Applicant: Arkray, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
Recent devices under product code CIG
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