ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)— 510(k) K973369
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K973369 for ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM), Substantially Equivalent on 1997-11-21. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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More clearances from Roche Diagnostic Systems, Inc.
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