HERPES GROUP IGG ELISA TEST SYSTEM— 510(k) K963645
Substantially EquivalentArmkel, LLC
FDA 510(k) clearance K963645 for HERPES GROUP IGG ELISA TEST SYSTEM, Substantially Equivalent on 1997-02-04. Applicant: Armkel, LLC. Device class: 2.
Clearance details
- Applicant
- Armkel, LLC
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frederick, MD, US
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