RAICHEM CREATININE URINE STANDARD— 510(k) K011126
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K011126 for RAICHEM CREATININE URINE STANDARD, Substantially Equivalent on 2001-05-02. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Columbia, MD, US
Recent devices under product code JIT
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