RAICHEM PHOSPORUS REAGENT— 510(k) K003012
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K003012 for RAICHEM PHOSPORUS REAGENT, Substantially Equivalent on 2000-10-25. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code CEO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1580
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Columbia, MD, US
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