STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 by ORASURE TECHNOLOGIES, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

Manufacturer

ORASURE TECHNOLOGIES, INC.

Date Cleared

2000-05-15

(98 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K093989,K101746,K103227

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

N/A