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.. Device class: 2.
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Inova Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.