The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Legionella Culture Confirmatin Kit.
| Device ID | K851271 |
| 510k Number | K851271 |
| Device Name: | LEGIONELLA CULTURE CONFIRMATIN KIT |
| Classification | Antisera, Fluorescent, All Types, Hemophilus Spp. |
| Applicant | GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Thomas H Adams |
| Correspondent | Thomas H Adams GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | GRO |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-07-08 |