The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Rapid Identi. Test For Mycobacterium Tb Complex.
Device ID | K862614 |
510k Number | K862614 |
Device Name: | RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX |
Classification | Dna-reagents, Mycobacterium Spp. |
Applicant | GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
Contact | Adams, Phd |
Correspondent | Adams, Phd GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego, CA 92123 |
Product Code | LQF |
CFR Regulation Number | 866.3370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-09 |
Decision Date | 1986-11-10 |