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MCC – Dna-Probe, Haemophilus Spp.
Dna-Probe, Haemophilus Spp.
FDA product code
MCC
· Class II (moderate risk) · 21 CFR 866.3300 ·
Microbiology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Gen-Probe, Inc.
2
510(k) clearances
510(k)
Device
Applicant
Decision
K901397
Accuprobe Listeria Monocytogenes Culture Confirma.
MCC · Traditional
Gen-Probe, Inc.
06/20/1990
SE
K897079
Accuprobe Haeomphilus Influenzae Culture
MCC · Traditional
Gen-Probe, Inc.
03/08/1990
SE