Cleared Traditional

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET

K893506 · Innotron of Oregon, Inc. · Chemistry
Aug 1989
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K893506 is an FDA 510(k) clearance for the INNOFLUOR CARBAMAZEPINE CALIBRATOR SET, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 15, 1989, 102 days after receiving the submission on May 5, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K893506 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1989
Decision Date August 15, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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