COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT— 510(k) K982848
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K982848 for COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT, Substantially Equivalent on 1998-10-01. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code MRR
view all- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K210801 — AXINON® LDL-p Test System
- K161691 — Direct LDL Cholesterol (LDL)
- K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
- K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
More clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.