ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT— 510(k) K914853
Substantially EquivalentReads Medical Products, Inc.
FDA 510(k) clearance K914853 for ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT, Substantially Equivalent on 1992-01-15. Applicant: Reads Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Reads Medical Products, Inc.
- Product code
- Code LJM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminster, CO, US
Recent devices under product code LJM
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