Cleared Traditional

CK-MB IMMUNOASSAY CONTROL

K905623 · Seradyn, Inc. · Chemistry
Feb 1991
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K905623 is an FDA 510(k) clearance for the CK-MB IMMUNOASSAY CONTROL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 22, 1991, 70 days after receiving the submission on December 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K905623 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date February 22, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJT Enzyme Controls (assayed And Unassayed)

All 96
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
K090940 · Astoria-Pacific, Inc. · Dec 2009
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · Quantimetrix Corp. · Oct 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · Cliniqa Corporation · Mar 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · Bayer Healthcare, LLC · Jan 2003
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · Bio-Rad · May 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad · Sep 2001