BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

Microbiologics, Inc.

The following data is part of a premarket notification filed by Microbiologics, Inc. with the FDA for Bd Max Enteric Parasite Control Panel, Bd Max Enteric Parasite 20-day Qc Panel.

Pre-market Notification Details

Device IDK181711
510k NumberK181711
Device Name:BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
ClassificationAssayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Applicant Microbiologics, Inc. 200 Cooper Avenue North St. Cloud,  MN  56303
ContactTina Sobania
CorrespondentTina Sobania
Microbiologics, Inc. 200 Cooper Avenue North St. Cloud,  MN  56303
Product CodePMN  
CFR Regulation Number866.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-28
Decision Date2018-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
70845357041394 K181711 000
70845357041097 K181711 000

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