Product code GRO— Microbiology

BACTOGEN-H. INFLUENZAE TYPE B

Classification name: Antisera, Fluorescent, All Types, Hemophilus Spp.
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Total cleared: 4
First cleared: 1980-04-04
Most recent: 1985-07-08

Market context for product code GRO

FDA has cleared 4 devices under product code GRO between 1980 and 1985, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19851 clearance
19841 clearance
19802 clearances

Top applicants under product code GRO

Remel Co.1 clearance
Pharmacia, Inc.1 clearance
Gen-Probe, Inc.1 clearance
Armkel, LLC1 clearance

Recent clearances under product code GRO

K851271 — LEGIONELLA CULTURE CONFIRMATIN KITGen-Probe, Inc.·1985-07-08
K834067 — LEGIONELLA DIFFERENTIATION DISKRemel Co.·1984-01-03
K802423 — PHADEBACT HAEMOPHILUS TESTPharmacia, Inc.·1980-11-12
K800493 — BACTOGEN-H. INFLUENZAE TYPE BArmkel, LLC·1980-04-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.