BD MAX MRSA ASSAY, BD MAX INSTRUMENT

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)

The following data is part of a premarket notification filed by Bd Diagnostics (geneohm Sciences Canada, Inc) with the FDA for Bd Max Mrsa Assay, Bd Max Instrument.

Pre-market Notification Details

• Device ID: K120138
• 510k Number: K120138
• Device Name: BD MAX MRSA ASSAY, BD MAX INSTRUMENT
• Classification: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
• Applicant: BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) 7 LOVETON CIRCLE, MAIL CODE 614 Sparks, MD 21152
• Contact: Raymond J Boule
• Correspondent: Raymond J Boule; BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) 7 LOVETON CIRCLE, MAIL CODE 614 Sparks, MD 21152
• Product Code: NQX
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-17
• Decision Date: 2012-07-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382904429539	K120138	000