JHR · Class II · 21 CFR 866.5510

FDA Product Code JHR: Radioimmunoassay, Immunoglobulins (d, E)

Leading manufacturers include Diagnostic Products Corp., Pharmacia, Inc. and Roche Diagnostics.

9
Total
9
Cleared
52d
Avg days
1984
Since

FDA 510(k) Cleared Radioimmunoassay, Immunoglobulins (d, E) Devices (Product Code JHR)

9 devices
1–9 of 9
Cleared Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
K061970
Roche Diagnostics
Immunology · 50d
Cleared Feb 08, 1999
ELECYS IGE ASSAY
K984326
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Feb 14, 1996
IMMILITE TOTAL IGE
K960067
Diagnostic Products Corp.
Immunology · 40d
Cleared Aug 16, 1993
IMMULITE TOTAL IGE
K931703
Diagnostic Products Corp.
Immunology · 132d
Cleared Jul 31, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K903000
Ventrex Laboratories, Inc.
Immunology · 22d
Cleared May 03, 1990
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
K901859
Diagnostic Products Corp.
Immunology · 9d
Cleared Aug 04, 1988
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616
Pharmacia, Inc.
Immunology · 41d
Cleared Oct 20, 1987
PHARMACIA IGE EIA
K873077
Pharmacia, Inc.
Immunology · 76d

About Product Code JHR - Regulatory Context