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LQO — Dna-Reagents, Campylobacter Spp. Class I

FDA Device Classification

Classification Details

Product Code
LQO
Device Class
Class I
Regulation Number
866.3110
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894712gen-probeACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATIONNovember 14, 1989
K873670molecular biosystemsSNAP CAMPYLOBACTOR DIAGNOSTIC KITJune 8, 1988
K875101wampole laboratoriesVIROGEN CMV ANTIBODY TESTMarch 1, 1988
K863270integrated geneticsGENE-TRAK CAMPYLOBACTER ASSAYAugust 31, 1987