MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA— 510(k) K042389
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K042389 for MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA, Substantially Equivalent on 2004-09-14. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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