COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS— 510(k) K912489
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K912489 for COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS, Substantially Equivalent on 1991-07-24. Applicant: Immuno Concepts, Inc.. Device class: 1.
Clearance details
- Applicant
- Immuno Concepts, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.