LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES— 510(k) K893740
Substantially EquivalentReference Diagnostics, Inc.
FDA 510(k) clearance K893740 for LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES, Substantially Equivalent on 1990-03-19. Applicant: Reference Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Reference Diagnostics, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, MA, US
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