CIC · Class II · 21 CFR 862.1145

FDA Product Code CIC: Cresolphthalein Complexone, Calcium

Leading manufacturers include Em Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Abbott Laboratories.

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 Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292
Roche Diagnostic Systems, Inc.
Chemistry · 71d
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 Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
COBAS READY CALCIUM REAGENT
K896224
Roche Diagnostic Systems, Inc.
Chemistry · 291d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407
Abbott Laboratories
Chemistry · 70d
Cleared Sep 05, 1989
CALCIUM TEST ITEM NUMBER: 65409
K893778
Em Diagnostic Systems, Inc.
Chemistry · 106d
Cleared May 03, 1989
IQ CALCIUM
K891217
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 57d
Cleared Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
K884986
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 14, 1987
PARAMAX CALCIUM REAGENT
K873519
Baxter Healthcare Corp
Chemistry · 104d
Cleared Aug 18, 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306
Boehringer Mannheim Corp.
Chemistry · 64d
Cleared May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Nov 13, 1986
VISION (TM) CALCIUM
K863670
Abbott Laboratories
Chemistry · 56d
Cleared Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Jul 29, 1986
ANALYST ANALYTICAL TEST ROTORS
K862274
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Apr 03, 1986
A-GENT LIQUID CALCIUM
K860425
Abbott Laboratories
Chemistry · 58d
Cleared Feb 06, 1985
CALCIUM
K850281
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Aug 29, 1984
SYSTEMATE CALCIUM 67214
K843152
Em Diagnostic Systems, Inc.
Chemistry · 19d
Cleared Dec 19, 1980
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923
Beckman Instruments, Inc.
Chemistry · 31d
Cleared Jul 27, 1978
CALCIUM REAGENT SYSTEM NO. 585
K780983
Sigma Chemical Co.
Chemistry · 43d

About Product Code CIC - Regulatory Context