STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

Enzyme Immunoassay, Phencyclidine

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Pcp Intercept Micro-plate Eia, Model 11541.

Pre-market Notification Details

• Device ID: K000399
• 510k Number: K000399
• Device Name: STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
• Classification: Enzyme Immunoassay, Phencyclidine
• Applicant: ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Contact: R. Sam Neidbala
• Correspondent: R. Sam Neidbala; ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799
• Product Code: LCM
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-07
• Decision Date: 2000-05-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00608337000740	K000399	000
00608337000733	K000399	000
00608337000726	K000399	000