Cleared Traditional

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

K981926 · Emd Chemicals, Inc. · Toxicology
Jul 1998
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K981926 is an FDA 510(k) clearance for the ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 22, 1998, 50 days after receiving the submission on June 2, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K981926 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1998
Decision Date July 22, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

Similar Devices — DLJ Calibrators, Drug Specific

All 122
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K132090 · Randox Laboratories, Ltd. · Aug 2013
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617 · Thermo Fisher Scientific · Jul 2009
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · Dade Behring, Inc. · Sep 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · Dade Behring, Inc. · Jun 2006