The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Streptococcus Pneumoniae Culture Confir..
Device ID | K902908 |
510k Number | K902908 |
Device Name: | ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. |
Classification | Dna-probe, Strep Pneumoniae |
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 | MCT |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-02 |
Decision Date | 1990-08-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15420045506176 | K902908 | 000 |