GRO · Class II · 21 CFR 866.3300

FDA Product Code GRO: Antisera, Fluorescent, All Types, Hemophilus Spp.

Leading manufacturers include Armkel, LLC, Pharmacia, Inc. and Remel Co..

4
Total
4
Cleared
52d
Avg days
1980
Since

FDA 510(k) Cleared Antisera, Fluorescent, All Types, Hemophilus Spp. Devices (Product Code GRO)

4 devices
1–4 of 4
Cleared Jul 08, 1985
LEGIONELLA CULTURE CONFIRMATIN KIT
K851271
Gen-Probe, Inc.
Microbiology · 98d
Cleared Jan 03, 1984
LEGIONELLA DIFFERENTIATION DISK
K834067
Remel Co.
Microbiology · 39d
Cleared Nov 12, 1980
PHADEBACT HAEMOPHILUS TEST
K802423
Pharmacia, Inc.
Microbiology · 40d
Cleared Apr 04, 1980
BACTOGEN-H. INFLUENZAE TYPE B
K800493
Armkel, LLC
Microbiology · 31d

About Product Code GRO - Regulatory Context