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
67 devices
25–48 of 67
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
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
TECHNICON RA-1000 SYS IRON FOR SERUM
K843255
Technicon Instruments Corp.
Chemistry · 25d
Cleared Jun 22, 1984
PARAMAX IRON REAGENT
K841886
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
PARAMAX IRON BLANK REAGENT
K841887
American Dade
Chemistry · 46d
Cleared Nov 03, 1983
SERUM IRON & TIBC#65084 & 65085
K833017
Emd Chemicals, Inc.
Chemistry · 58d