CHEM TRAK ACCUMETER— 510(k) K943599

Substantially Equivalent

Chemtrak, Inc.

FDA 510(k) clearance K943599 for CHEM TRAK ACCUMETER, Substantially Equivalent on 1995-03-21. Applicant: Chemtrak, Inc.. Device class: 1.

Clearance details

Applicant: Chemtrak, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1994-07-06
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.