DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM— 510(k) K981306
Substantially EquivalentDiamedix Corp.
FDA 510(k) clearance K981306 for DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM, Substantially Equivalent on 1998-09-29. Applicant: Diamedix Corp.. Device class: 2.
Clearance details
- Applicant
- Diamedix Corp.
- 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
- Miami, FL, US
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