Atlas FDA

LQO

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Dna-Reagents, Campylobacter Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3110
Medical specialty
Microbiology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712)Gen-Probe, Inc.1989-11-14
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670)Molecular Biosystems, Inc.1988-06-08
VIROGEN CMV ANTIBODY TEST (K875101)Wampole Laboratories1988-03-01
GENE-TRAK CAMPYLOBACTER ASSAY (K863270)Integrated Genetics1987-08-31

Track LQO automatically

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