COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR— 510(k) K141928
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K141928 for COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR, Substantially Equivalent on 2014-11-25. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DKB
view all- K133710 — LZI MULTIPLE ANALYTE SET A; B; C DRUGS OF ABUSE CONTROLS
- K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
- K092266 — RANDOX METHAMPHETAMINE ASSAY
- K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
- K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
More clearances from Roche Diagnostics Operations (Rdo)
view allData sourced from openFDA. This site is unofficial and independent of the FDA.