The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Rapid Ident. Test For Mycobacterium Avium Complex.
| Device ID | K862613 |
| 510k Number | K862613 |
| Device Name: | RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX |
| Classification | Dna-reagents, Mycobacterium Spp. |
| Applicant | GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Adams, Phd |
| Correspondent | Adams, Phd GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | LQF |
| CFR Regulation Number | 866.3370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-09 |
| Decision Date | 1986-11-10 |