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 Olympus Corp..

67
Total
67
Cleared
62d
Avg days
1977
Since
67 devices
49–67 of 67
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 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