The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Group B Streptococcus Culture Confirma..
| Device ID | K894711 |
| 510k Number | K894711 |
| Device Name: | ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | John F Bruni,phd |
| Correspondent | John F Bruni,phd GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-11-14 |