RHEUMELISA II HISTONE ANTIBODY TEST KIT— 510(k) K932679
Substantially EquivalentBiowhittaker Molecular Applications, Inc.
FDA 510(k) clearance K932679 for RHEUMELISA II HISTONE ANTIBODY TEST KIT, Substantially Equivalent on 1993-08-23. Applicant: Biowhittaker Molecular Applications, Inc.. Device class: 2.
Clearance details
- Applicant
- Biowhittaker Molecular Applications, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walkersville, MD, US
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