The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Listeria Monocytogenes Culture Confirma..
| Device ID | K901397 |
| 510k Number | K901397 |
| Device Name: | ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. |
| Classification | Dna-probe, Haemophilus Spp. |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Connie Kirby |
| Correspondent | Connie Kirby GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | MCC |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506220 | K901397 | 000 |