CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)— 510(k) K893465
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K893465 for CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST), Substantially Equivalent on 1989-07-25. Applicant: Immuno Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno Concepts, Inc.
- Product code
- Code LKQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- 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.