PRECISET TDM I AND PRECISET TDM II CALIBRATORS— 510(k) K031856
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K031856 for PRECISET TDM I AND PRECISET TDM II CALIBRATORS, Substantially Equivalent on 2003-08-06. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics 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
- Abbreviated
- Location
- Indianapolis, IN, 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 Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.