CK/MB IMMUNO-ISOENZYME CONTROL SERUM— 510(k) K840793
Substantially EquivalentSeragen Diagnostics, Inc.
FDA 510(k) clearance K840793 for CK/MB IMMUNO-ISOENZYME CONTROL SERUM, Substantially Equivalent on 1984-04-13. Applicant: Seragen Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Seragen Diagnostics, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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