The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Legionella Rapid Diagnostic System.
| Device ID | K860498 |
| 510k Number | K860498 |
| Device Name: | GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM |
| Classification | Dna-reagents, Legionella |
| Applicant | GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Kacian, Ph.d. |
| Correspondent | Kacian, Ph.d. GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | LQH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-10 |
| Decision Date | 1986-07-16 |