READS RF TEST KIT FOR IGM RHEUMATOID FACTOR— 510(k) K863238
Substantially EquivalentBiostar Medical Products, Inc.
FDA 510(k) clearance K863238 for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR, Substantially Equivalent on 1986-10-08. Applicant: Biostar Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Biostar Medical Products, Inc.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, VA, US
Recent devices under product code DHR
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