VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

Antisera, Control For Nontreponemal Tests

NCS DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Vdrl Carbon Antigen Test S900500, S900250 & S90010.

Pre-market Notification Details

• Device ID: K851504
• 510k Number: K851504
• Device Name: VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
• Classification: Antisera, Control For Nontreponemal Tests
• Applicant: NCS DIAGNOSTICS, INC. 3069 UNIVERSAL DR. Mississauga, Ontario, CA L4x2e2
• Contact: Ed Rayner
• Correspondent: Ed Rayner; NCS DIAGNOSTICS, INC. 3069 UNIVERSAL DR. Mississauga, Ontario, CA L4x2e2
• Product Code: GMP
• CFR Regulation Number: 866.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-04-15
• Decision Date: 1985-08-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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