CEDIA DAU MULTI-DRUG CALIBRATORS— 510(k) K980853
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K980853 for CEDIA DAU MULTI-DRUG CALIBRATORS, Substantially Equivalent on 1998-04-21. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- 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
- Pleasanton, CA, 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 Boehringer Mannheim Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.