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 Eastman Kodak Company.

67
Total
67
Cleared
62d
Avg days
1977
Since
67 devices
49–67 of 67
Cleared Apr 30, 1985
SANDARE IRON PROCEDURE
K851394
Sandare Chemical Co., Inc.
Chemistry · 21d
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
Cleared May 25, 1983
SERUM IRON-PTF-600
K831201
American Monitor Corp.
Chemistry · 42d
Cleared May 24, 1982
SPIN CHEM REAGENTS & STANDARDS
K821184
Smithkline Diagnostics, Inc.
Chemistry · 27d
Cleared Dec 03, 1981
SERUM IRON REAGENT SET
K812840
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Oct 19, 1981
DIRECT IRON REAGENT SET
K812777
The Dow Chemical Co.
Chemistry · 14d
Cleared May 28, 1980
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Jan 26, 1979
TOTAL IRON IN SERUM
K782160
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865
Stanbio Laboratory
Chemistry · 28d
Cleared Nov 03, 1977
SERUM IRON
K771838
Gamma Enterprises, Inc.
Chemistry · 43d