GRP · Class II · 21 CFR 866.3300

FDA Product Code GRP: Antisera, All Types, H. Influenza

Leading manufacturers include Hyland Therapeutic Div., Travenol Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Seragen Diagnostics, Inc..

6
Total
6
Cleared
63d
Avg days
1982
Since

FDA 510(k) Cleared Antisera, All Types, H. Influenza Devices (Product Code GRP)

6 devices
1–6 of 6
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967
Armkel, LLC
Microbiology · 69d
Cleared Dec 27, 1985
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490
American Micro Scan
Microbiology · 45d
Cleared Sep 29, 1983
H-FLU B ELISA TEST
K831525
Seragen Diagnostics, Inc.
Microbiology · 140d
Cleared Jun 01, 1982
BBL DIRECTIGEN MENINGITIS TEST KIT
K821266
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 29d
Cleared Mar 11, 1982
HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
K820192
Hyland Therapeutic Div., Travenol Laboratories
Microbiology · 45d

About Product Code GRP - Regulatory Context