CIJ · Class II · 21 CFR 862.1070

FDA Product Code CIJ: Saccharogenic, Amylase

Leading manufacturers include Harleco, Pointe Scientific, Inc., and Coulter Electronics, Inc..

31
Total
31
Cleared
84d
Avg days
1976
Since

FDA 510(k) Cleared Saccharogenic, Amylase Devices (Product Code CIJ)

31 devices
1–24 of 31
Cleared Dec 23, 2002
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396
Pointe Scientific, Inc.,
Chemistry · 75d
Cleared Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817
Bayer Corp.
Chemistry · 56d
Cleared Jun 21, 1996
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211
Randox Laboratories, Ltd.
Chemistry · 347d
Cleared Dec 11, 1995
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494
Emd Chemicals, Inc.
Chemistry · 255d
Cleared Aug 01, 1994
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735
Pointe Scientific, Inc.,
Chemistry · 165d
Cleared Mar 11, 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010
Data Medical Associates, Inc.
Chemistry · 66d
Cleared Oct 18, 1993
OLYMPUS AMYLASE REAGENT
K931301
Olympus Corp.
Chemistry · 217d
Cleared May 26, 1993
BIOTROL AMYLASE CNPG3
K931141
Biotrol, USA, Inc.
Chemistry · 82d
Cleared Jan 03, 1989
-AMYLASE EPS
K882225
Boehringer Mannheim Corp.
Chemistry · 222d
Cleared Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250
Roche Diagnostic Systems, Inc.
Chemistry · 64d
Cleared Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572
Instrumentation Laboratory CO
Chemistry · 48d
Cleared Sep 04, 1987
BIOTROL ALPHA AMYLASE
K872831
Biotrol, USA, Inc.
Chemistry · 49d
Cleared Jun 03, 1987
D.A.T. (TM) AMYLASE REAGENT
K871943
Behring Diagnostics, Inc.
Chemistry · 15d
Cleared Jan 21, 1987
AMYLASE REAGENT
K864356
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Nov 13, 1986
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
K863719
Technicon Instruments Corp.
Chemistry · 51d
Cleared Aug 01, 1986
DART AMYLASE-D.S. REAGENT SYSTEM
K862370
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Jul 01, 1986
AMYLASE PROCEDURE
K861664
Data Medical Associates, Inc.
Chemistry · 62d
Cleared May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Jan 07, 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951
Behring Diagnostics, Inc.
Chemistry · 104d
Cleared Jul 12, 1985
X-AMYLASE ASSAY KIT
K852636
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Feb 04, 1984
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Dec 31, 1981
DADE COLORIMETRIC AMYLASE
K813529
American Dade
Chemistry · 14d
Cleared Oct 02, 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
K812594
Harleco
Chemistry · 21d

About Product Code CIJ - Regulatory Context