HEMAGEN CRP 150 KIT (EIA METHOD)— 510(k) K960324
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K960324 for HEMAGEN CRP 150 KIT (EIA METHOD), Substantially Equivalent on 1996-03-12. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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