COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)— 510(k) K951639
Substantially EquivalentIncstar Corp.
FDA 510(k) clearance K951639 for COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE), Substantially Equivalent on 1995-10-13. Applicant: Incstar Corp.. Device class: 2.
Clearance details
- Applicant
- Incstar Corp.
- Product code
- Code DAE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
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