JIY · Class I · 21 CFR 862.1410

FDA Product Code JIY: Photometric Method, Iron (non-heme)

Leading manufacturers include Em Diagnostic Systems, Inc., Data Medical Associates, Inc. and Pointe Scientific, Inc.,.

67
Total
67
Cleared
62d
Avg days
1977
Since

FDA 510(k) Cleared Photometric Method, Iron (non-heme) Devices (Product Code JIY)

67 devices
1–24 of 67
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793
Dade Behring, Inc.
Chemistry · 42d
Cleared Mar 08, 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264
Dade Behring, Inc.
Chemistry · 35d
Cleared Aug 25, 2005
SENTINEL IRON LIQUID
K051115
Sentinel Ch. Srl
Chemistry · 115d
Cleared May 21, 2004
VITALAB IRON REAGENT
K033983
Clinical Data, Inc.
Chemistry · 150d
Cleared May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816
Diagnostic Chemicals , Ltd.
Chemistry · 62d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097
Wiener Laboratories Saic
Chemistry · 57d
Cleared May 01, 1998
IRON
K981241
Abbott Laboratories
Chemistry · 25d
Cleared Nov 04, 1997
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933
Diagnostic Chemicals , Ltd.
Chemistry · 20d
Cleared Aug 15, 1997
IL TEST IRON
K972363
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Feb 20, 1997
IRON REAGENT
K964913
Derma Media Lab., Inc.
Chemistry · 73d
Cleared Nov 18, 1996
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588
Pointe Scientific, Inc.,
Chemistry · 208d
Cleared Feb 10, 1995
ACE IRON REAGENT
K944911
Schiapparelli Biosystems, Inc.
Chemistry · 128d
Cleared Dec 02, 1994
IRON QVET
K943029
Prisma Systems
Chemistry · 158d
Cleared Nov 15, 1994
DMA IRON PROCEDURE
K944462
Data Medical Associates, Inc.
Toxicology · 64d
Cleared Dec 16, 1993
IRON TEST
K935176
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Apr 21, 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Dec 18, 1992
OLYMPUS IRON REAGENT
K924691
Olympus Corp.
Chemistry · 92d
Cleared Sep 28, 1992
OLYMPUS IRON REAGENT
K923565
Olympus Corp.
Chemistry · 73d
Cleared May 01, 1991
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
K911170
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared Feb 04, 1991
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143
Eastman Kodak Company
Chemistry · 21d
Cleared Jul 27, 1990
TOTAL IRON FOR MANUAL/AUTOMATED
K902877
Catachem, Inc.
Chemistry · 25d
Cleared Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
K902173
Coulter Corp.
Chemistry · 29d
Cleared May 17, 1990
IRON/TOTAL IRON BINDING CAPACITY
K901561
Tech-Co, Inc.
Chemistry · 44d
Cleared Mar 19, 1990
IRON LIQUID STABLE REAGENT
K900902
Medical Analysis Systems, Inc.
Chemistry · 20d

About Product Code JIY - Regulatory Context