COBAS C BILIRUBIN TOTAL GEN.3— 510(k) K131544
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K131544 for COBAS C BILIRUBIN TOTAL GEN.3, Substantially Equivalent on 2013-07-17. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CIG
view allMore clearances from Roche Diagnostics
view allRecalls naming K131544
K-number listed on FDA's recall record- Z-0153-2020 — Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
- Z-1145-2019 — Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates 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 K131544.
Data sourced from openFDA. This site is unofficial and independent of the FDA.