S-UREA-N, IN VITRO DIAG FOR BUN— 510(k) K761152
Substantially EquivalentAdvanced Biomedical Methods, Inc.
FDA 510(k) clearance K761152 for S-UREA-N, IN VITRO DIAG FOR BUN, Substantially Equivalent on 1976-12-09. Applicant: Advanced Biomedical Methods, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Biomedical Methods, Inc.
- Product code
- Code CDL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDL
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