TOTAL BILIRUBIN FOR DEMAND ANALYZER— 510(k) K844243
Substantially EquivalentAdvanced Biomedical Methods, Inc.
FDA 510(k) clearance K844243 for TOTAL BILIRUBIN FOR DEMAND ANALYZER, Substantially Equivalent on 1985-01-03. Applicant: Advanced Biomedical Methods, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Biomedical Methods, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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