The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Neisseria Gonorrhoeae Culture Confirma..
Device ID | K895583 |
510k Number | K895583 |
Device Name: | ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. |
Classification | Dna-reagents, Neisseria |
Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Contact | Bruni, Phd |
Correspondent | Bruni, Phd GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Product Code | LSL |
CFR Regulation Number | 866.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-15 |
Decision Date | 1989-11-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15420045506107 | K895583 | 000 |