STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

Enzyme Immunoassay, Barbiturate

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Barbiturates Intercept Micro-plate Eia, Model 1108i.

Pre-market Notification Details

• Device ID: K001976
• 510k Number: K001976
• Device Name: STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
• Classification: Enzyme Immunoassay, Barbiturate
• 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: DIS
• CFR Regulation Number: 862.3150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-29
• Decision Date: 2000-12-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00608337000221	K001976	000
00608337000214	K001976	000
00608337000207	K001976	000