BIOTEL MICROALBUMINURIA (TM)— 510(k) K894169
Substantially EquivalentAmerican Diagnostic Corp.
FDA 510(k) clearance K894169 for BIOTEL MICROALBUMINURIA (TM), Substantially Equivalent on 1989-09-18. Applicant: American Diagnostic Corp.. Device class: 1.
Clearance details
- Applicant
- American Diagnostic Corp.
- Product code
- Code JIR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oak Brook, IL, US
Recent devices under product code JIR
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