COBAS INTEGRA CREATININE PLUS VER.2 ASSAY— 510(k) K024098
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K024098 for COBAS INTEGRA CREATININE PLUS VER.2 ASSAY, Substantially Equivalent on 2002-12-19. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code JFY
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view allRecalls naming K024098
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024098.
Data sourced from openFDA. This site is unofficial and independent of the FDA.