IS-ANTI-PR3 IGG ELISA TEST SYSTEM— 510(k) K983740
Substantially EquivalentColumbia Bioscience, Inc.
FDA 510(k) clearance K983740 for IS-ANTI-PR3 IGG ELISA TEST SYSTEM, Substantially Equivalent on 1998-11-18. Applicant: Columbia Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Columbia Bioscience, 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
- Columbia, MD, US
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