ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2— 510(k) K033009
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K033009 for ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2, Substantially Equivalent on 2003-10-16. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
view allRecalls naming K033009
K-number listed on FDA's recall record- Z-0104-2021 — Albumin Gen.2, Catalog 05166861190
- Z-0152-2020 — Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033009.
Data sourced from openFDA. This site is unofficial and independent of the FDA.