HPL RIA KIT— 510(k) K863188

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K863188 for HPL RIA KIT, Substantially Equivalent on 1986-09-25. Applicant: Biotecx Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code JMX
Device class: Class 1
Regulation: 21 CFR 862.1515
Advisory panel: Clinical Chemistry
Date received: 1986-08-19
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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