STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

Enzyme Immunoassay, Methadone

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Methadone Intercept Micro-plate Eia, Model 11421.

Pre-market Notification Details

• Device ID: K002010
• 510k Number: K002010
• Device Name: STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
• Classification: Enzyme Immunoassay, Methadone
• Applicant: ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Contact: R. Sam Niedbala
• Correspondent: R. Sam Niedbala; ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Product Code: DJR
• CFR Regulation Number: 862.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-03
• Decision Date: 2000-11-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00608337000344	K002010	000
00608337000337	K002010	000
00608337000320	K002010	000