The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Aptima Combo 2 Assay.
| Device ID | K003395 |
| 510k Number | K003395 |
| Device Name: | GEN-PROBE APTIMA COMBO 2 ASSAY |
| Classification | Dna-reagents, Neisseria |
| Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Contact | E. Joseph Mcmullen |
| Correspondent | E. Joseph Mcmullen GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25420045506272 | K003395 | 000 |
| 25420045506265 | K003395 | 000 |
| 15420045505735 | K003395 | 000 |
| 15420045500259 | K003395 | 000 |
| 15420045500242 | K003395 | 000 |