Panels › Microbiology › Product code GRO · Class 2
Antisera, Fluorescent, All Types, Hemophilus Spp.
Regulation 866.3300
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GRO
| Company | 510(k)s | Recalls |
|---|---|---|
| Armkel, LLC | 1 | 0 |
| Becton Dickinson & Co. | 0 | 1 |
| Gen-Probe, Inc. | 1 | 0 |
| Pharmacia, Inc. | 1 | 0 |
| Remel Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 1985 | K851271 | LEGIONELLA CULTURE CONFIRMATIN KIT Gen-Probe, Inc. | GRO |
| Jan 3, 1984 | K834067 | LEGIONELLA DIFFERENTIATION DISK Remel Co. | GRO |
| Nov 12, 1980 | K802423 | PHADEBACT HAEMOPHILUS TEST Pharmacia, Inc. | GRO |
| Apr 4, 1980 | K800493 | BACTOGEN-H. INFLUENZAE TYPE B Armkel, LLC | GRO |
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