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 Dade Behring, Inc..

67
Total
67
Cleared
62d
Avg days
1977
Since
67 devices
25–48 of 67
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 Mar 08, 1989
BIOTROL IRON REAGENT
K890395
Biotrol, USA, Inc.
Chemistry · 42d
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 03, 1989
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
K890034
American Monitor Corp.
Chemistry · 30d
Cleared Dec 16, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355
Eastman Kodak Company
Chemistry · 60d
Cleared Oct 12, 1988
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
K883792
Catachem, Inc.
Chemistry · 35d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 28, 1988
IRON PROCEDURE
K881167
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
IRON TEST
K881202
Sclavo, Inc.
Chemistry · 38d
Cleared Mar 24, 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467
Stanbio Laboratory
Chemistry · 50d
Cleared Feb 11, 1988
IRON PROCEDURE
K874918
Data Medical Associates, Inc.
Chemistry · 70d
Cleared Nov 23, 1987
WAKO(TM) FE C
K874263
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Apr 13, 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Apr 08, 1987
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
K871284
American Research Products Co.
Chemistry · 8d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 12, 1987
RAICHEM (TM)SERUM IRON AND TIBC REAGENTS
K864819
Reagents Applications, Inc.
Chemistry · 65d
Cleared Jan 21, 1987
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
K864882
Pointe Scientific, Inc.,
Chemistry · 40d
Cleared Nov 24, 1986
FERROFAST
K863109
J. D. Assoc.
Chemistry · 103d
Cleared Sep 11, 1986
IRON PROCEDURE
K863266
Data Medical Associates, Inc.
Chemistry · 17d
Cleared May 29, 1986
IRON PROCEDURE
K861652
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Apr 03, 1986
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
K860799
Technicon Instruments Corp.
Chemistry · 30d
Cleared Mar 14, 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478
Sterling Diagnostics, Inc.
Chemistry · 35d