Cleared Traditional

PRECISET DAT PLUS

K021393 · Quantimetrix Corp. · Toxicology
Jun 2002
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K021393 is an FDA 510(k) clearance for the PRECISET DAT PLUS, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on June 13, 2002, 42 days after receiving the submission on May 2, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K021393 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2002
Decision Date June 13, 2002
Days to Decision 42 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

Similar Devices — DKB Calibrators, Drug Mixture

All 93
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K141928 · Roche Diagnostics Operations (Rdo) · Nov 2014
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
K133710 · Lin-Zhi International, Inc. · Feb 2014
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
K120936 · Microgenics Corporation · Dec 2012
RANDOX METHAMPHETAMINE ASSAY
K092266 · Randox Laboratories, Ltd. · May 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · Microgenics Corp. · Apr 2011
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
K090939 · Roche Diagnostics · Jun 2009