RAICHEM PREALBUMIN SPIA— 510(k) K972812
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K972812 for RAICHEM PREALBUMIN SPIA, Substantially Equivalent on 1997-08-28. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code DDS
- Device class
- Class 1
- Regulation
- 21 CFR 866.5060
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code DDS
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