HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO— 510(k) K983924
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K983924 for HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO, Substantially Equivalent on 1998-12-18. Applicant: Immuno Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno Concepts, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
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