The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Staphylococcus Aureus Culture Confirma..
| Device ID | K902213 |
| 510k Number | K902213 |
| Device Name: | ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA. |
| Classification | Dna-probe, Staphylococcus Aureus |
| 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 | MCS |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506183 | K902213 | 000 |