JIY · Class I · 21 CFR 862.1410

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

Leading manufacturers include Em Diagnostic Systems, Inc., Dade Behring, Inc. and Eastman Kodak Company.

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 May 01, 1998
IRON
K981241
Abbott Laboratories
Chemistry · 25d
Cleared Aug 15, 1997
IL TEST IRON
K972363
Instrumentation Laboratory CO
Chemistry · 51d
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 Feb 04, 1991
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143
Eastman Kodak Company
Chemistry · 21d
Cleared Oct 31, 1989
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Jun 16, 1989
IRON SYSTEM PACK REAGENTS
K892838
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jun 07, 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Dec 16, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355
Eastman Kodak Company
Chemistry · 60d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 13, 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020
Em Diagnostic Systems, Inc.
Chemistry · 32d

About Product Code JIY - Regulatory Context