The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Mycobacterium Kansasii Cult Confirm Test.
Device ID | K904463 |
510k Number | K904463 |
Device Name: | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST |
Classification | Dna-reagents, Mycobacterium 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 | LQF |
CFR Regulation Number | 866.3370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-01 |
Decision Date | 1990-11-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15420045506152 | K904463 | 000 |