BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY

Dna Probe, Nucleic Acid Amplification, Chlamydia

BECTON, DICKINSON & CO.

The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Chlamydia Trachomatis (ct) Qx Amplified Dna Assay.

Pre-market Notification Details

• Device ID: K140446
• 510k Number: K140446
• Device Name: BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
• Classification: Dna Probe, Nucleic Acid Amplification, Chlamydia
• Applicant: BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999
• Contact: Sherma Winston
• Correspondent: Sherma Winston; BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999
• Product Code: MKZ
• CFR Regulation Number: 866.3120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-21
• Decision Date: 2014-05-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382904429591	K140446	000