The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Mycoplasma Pneumonia Rapid Detect System.
| Device ID | K860574 |
| 510k Number | K860574 |
| Device Name: | GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM |
| Classification | Dna-reagents, Mycoplasma Spp. |
| Applicant | GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Daniel L Kacian |
| Correspondent | Daniel L Kacian GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | LQG |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-07-03 |