STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

Enzyme Immunoassay, Cannabinoids

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Cannabinoids Intercept Micro-plate Eia, Model 1118i.

Pre-market Notification Details

• Device ID: K002375
• 510k Number: K002375
• Device Name: STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
• Classification: Enzyme Immunoassay, Cannabinoids
• 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: LDJ
• CFR Regulation Number: 862.3870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-04
• Decision Date: 2001-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00608337000283	K002375	000
00608337000276	K002375	000
00608337000269	K002375	000