CIC · Class II · 21 CFR 862.1145

FDA Product Code CIC: Cresolphthalein Complexone, Calcium

Leading manufacturers include Em Diagnostic Systems, Inc., Diagnostic Chemicals, Ltd. (Usa) and Boehringer Mannheim Corp..

99
Total
99
Cleared
62d
Avg days
1976
Since

FDA 510(k) Cleared Cresolphthalein Complexone, Calcium Devices (Product Code CIC)

99 devices
1–24 of 99
Cleared May 02, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
K130870
Hitachi Chemical Diagnostics, Inc.
Chemistry · 34d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339
Siemens Healthcare Diagnostics, Inc.
Chemistry · 117d
Cleared Apr 26, 2007
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
K070249
Horiba Abx
Chemistry · 90d
Cleared Mar 24, 2006
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
K053401
Arkray, Inc.
Chemistry · 108d
Cleared Feb 15, 2005
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
K050077
Arkray, Inc.
Chemistry · 34d
Cleared Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009
Hemagen Diagnostics, Inc.
Chemistry · 67d
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652
Wiener Laboratories Saic
Chemistry · 45d
Cleared Apr 05, 2000
RANDOX CALCIUM
K000375
Randox Laboratories, Ltd.
Chemistry · 58d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
K991111
A.P. Total Care, Inc.
Chemistry · 54d
Cleared Jun 24, 1997
CALCIUM REAGENT
K971907
Carolina Liquid Chemistries Corp.
Chemistry · 32d
Cleared Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Mar 13, 1996
CALCIUM REAGENT
K955939
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Jan 05, 1995
CALCIUM REAGENT
K944258
Olympus America, Inc.
Chemistry · 126d
Cleared Feb 01, 1994
IL TEST CALCIUM
K931362
Instrumentation Laboratory CO
Chemistry · 321d
Cleared Sep 27, 1993
CALCIUM TEST ITEM NUMBER 65409
K932158
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Oct 19, 1992
OLYMPUS CALCIUM REAGENT
K924435
Olympus Corp.
Chemistry · 48d
Cleared Sep 15, 1992
MILES URINE CALCIUM METHOD
K923034
Heraeus Kulzer, Inc.
Chemistry · 88d
Cleared Jul 10, 1992
OLYMPUS CALCIUM REAGENT
K922233
Olympus Corp.
Chemistry · 59d
Cleared May 13, 1992
CALCIUM-ARSENAZO III REAGENT SET
K921625
Pointe Scientific, Inc.,
Chemistry · 37d
Cleared Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Oct 04, 1990
SYNERMED CALCIUM REAGENT KIT
K903233
Synermed, Inc.
Chemistry · 73d
Cleared Sep 13, 1990
CALCIUM ARSENAZO III REAGENT
K903896
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Aug 17, 1990
COBAS READY CALCIUM REAGENT
K896224
Roche Diagnostic Systems, Inc.
Chemistry · 291d
Cleared Jul 17, 1990
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
K902479
Amresco, Inc.
Chemistry · 42d

About Product Code CIC - Regulatory Context