CHOLESITE TEST SYSTEM— 510(k) K992132

Substantially Equivalent

Gds Technology, LLC

FDA 510(k) clearance K992132 for CHOLESITE TEST SYSTEM, Substantially Equivalent on 1999-08-20. Applicant: Gds Technology, LLC. Device class: 1.

Clearance details

Applicant: Gds Technology, LLC
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1999-06-23
Decision date: 1999-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.