Who is the manufacturer of STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

OraSure Technologies, Inc. filed the 510(k) submission for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (K000399).

What is the FDA product code for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

LCM. as a Class U device in the TX panel.

What is the regulatory pathway for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

K000399 · OraSure Technologies, Inc. · LCM · May 15, 2000 · TX

Device Facts

Record ID	K000399
Device Name	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
Applicant	OraSure Technologies, Inc.
Product Code	LCM · TX
Decision Date	May 15, 2000
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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