Cleared Traditional

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

K852391 · Helena Laboratories · Chemistry
Oct 1985
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K852391 is an FDA 510(k) clearance for the EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE, a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II — Special Controls, product code CFH), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 1, 1985, 118 days after receiving the submission on June 5, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K852391 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1985
Decision Date October 01, 1985
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFH — Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1440

Similar Devices — CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

All 12
SPOTCHEM II LDH TEST
K050790 · Arkray, Inc. · Jun 2005
CARESIDE LDH
K020484 · Careside, Inc. · Jul 2002
CLINISTAT LDH REAGENT TEST
K895138 · Heraeus Kulzer, Inc. · Oct 1989
IQ LDH
K894578 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
LACTATE DEHYDROGENASE (LDH-L)
K880630 · Tech-Co, Inc. · Mar 1988
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · Sterling Diagnostics, Inc. · Feb 1986