E. COLI 0157 LATEX TEST— 510(k) K903714

Substantially Equivalent

Pro-Lab, Inc.

FDA 510(k) clearance K903714 for E. COLI 0157 LATEX TEST, Substantially Equivalent on 1991-01-24. Applicant: Pro-Lab, Inc.. Device class: 1.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1990-08-14
Decision date: 1991-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

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K894221 — ROSCO PYRR1989-09-28
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Data sourced from openFDA. This site is unofficial and independent of the FDA.