Atlas FDA

LQF

15 FDA 510(k) clearances · Product code

124 daysmedian time to decision
244 days90th percentile
15clearances measured

FDA profile

Official device name
Dna-Reagents, Mycobacterium Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3370
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K921435)Gen-Probe, Inc.1992-07-23
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (K904463)Gen-Probe, Inc.1990-11-13
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (K897077)Gen-Probe, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494)Gen-Probe, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K897078)Gen-Probe, Inc.1990-05-02
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (K896492)Gen-Probe, Inc.1990-04-16
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST (K896493)Gen-Probe, Inc.1990-04-11
SNAP MYCOBACTERIA AVIUM COMPLEX (K900202)Syngene, Inc.1990-04-03
SNAP M. TUBERCULOSIS COMPLEX (K900292)Syngene, Inc.1990-04-03
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089)Gen-Probe, Inc.1989-03-13
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (K871795)Gen-Probe, Inc.1987-07-30
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA (K864597)Gen-Probe, Inc.1987-04-20
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX (K862613)Gen-Probe, Inc.1986-11-10
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX (K862614)Gen-Probe, Inc.1986-11-10
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM (K860782)Gen-Probe, Inc.1986-07-02

Track LQF automatically

Every clearance here is in the API, with alerts when new ones post.