QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA— 510(k) K893896
Substantially EquivalentBiostar Medical Products, Inc.
FDA 510(k) clearance K893896 for QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA, Substantially Equivalent on 1989-07-14. Applicant: Biostar Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Biostar Medical Products, 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
- Arlington, VA, US
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