STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Cocaine Metabolite Micro-plate Eia (orasure Device).

Pre-market Notification Details

• Device ID: K982061
• 510k Number: K982061
• Device Name: STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Contact: Sam R Niedbala
• Correspondent: Sam R Niedbala; ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Product Code: DIO
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-04
• Decision Date: 1998-08-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00608337000429	K982061	000
00608337000412	K982061	000