RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2— 510(k) K031101
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K031101 for RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2, Substantially Equivalent on 2003-06-16. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Columbia, MD, US
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