ABUSCREEN ONLINE OPIATES CALIBRATORS— 510(k) K910087
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K910087 for ABUSCREEN ONLINE OPIATES CALIBRATORS, Substantially Equivalent on 1991-02-04. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- 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
- Montclair, NJ, US
Recent devices under product code DKB
view all- K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
- 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
More clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.