ROCHE COBAS IBTEGRA REAGENT CASSETTES— 510(k) K964457
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K964457 for ROCHE COBAS IBTEGRA REAGENT CASSETTES, Substantially Equivalent on 1997-01-13. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JQB
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code JQB
view allMore clearances from Roche Diagnostic Systems, Inc.
view allRecalls naming K964457
K-number listed on FDA's recall record- Z-1146-2019 — Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.
- Z-1926-2015 — Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964457.
Data sourced from openFDA. This site is unofficial and independent of the FDA.