DAH · Class II · 21 CFR 866.5510

FDA Product Code DAH: Gamma Globulin, Antigen, Antiserum, Control

Leading manufacturers include Helena Laboratories, Orion Diagnostica, Inc. and Abbott Laboratories.

7
Total
7
Cleared
75d
Avg days
1986
Since

FDA 510(k) Cleared Gamma Globulin, Antigen, Antiserum, Control Devices (Product Code DAH)

7 devices
1–7 of 7
Cleared Apr 27, 1993
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
K931247
Helena Laboratories
Immunology · 47d
Cleared Jan 03, 1991
TITAN GEL
K905149
Helena Laboratories
Immunology · 49d
Cleared Jun 06, 1990
REP(R) IMMUNOFIX
K901805
Helena Laboratories
Immunology · 47d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
K884074
Orion Diagnostica, Inc.
Immunology · 30d
Cleared Sep 07, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN G
K883494
Technicon Instruments Corp.
Immunology · 22d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
K854944
Abbott Laboratories
Immunology · 260d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN M (IGM)
K862184
Dako Corp.
Immunology · 71d

About Product Code DAH - Regulatory Context