DGR · Class I · 21 CFR 866.5700

FDA Product Code DGR: Whole Human Serum, Antigen, Antiserum, Control

Leading manufacturers include Beckman Instruments, Inc., Kallestad Laboratories, Inc. and Bio-Rad.

5
Total
5
Cleared
72d
Avg days
1978
Since

FDA 510(k) Cleared Whole Human Serum, Antigen, Antiserum, Control Devices (Product Code DGR)

5 devices
1–5 of 5
Cleared Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K902220
Boehringer Mannheim Corp.
Immunology · 111d
Cleared Jan 09, 1987
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K865014
Bio-Rad
Immunology · 17d
Cleared Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
K790298
Kallestad Laboratories, Inc.
Immunology · 51d
Cleared Aug 31, 1978
ICS NORMAL CONTROL SERUM
K781355
Beckman Instruments, Inc.
Chemistry · 24d

About Product Code DGR - Regulatory Context