QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT— 510(k) K981328
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K981328 for QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT, Substantially Equivalent on 1998-06-19. Applicant: Inova Diagnostics, Inc..
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code MOB
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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