SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING— 510(k) K943925

Name: FDA 510(k) clearance K943925
Creator: U.S. Food and Drug Administration
Published: 1994-10-04

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K943925 for SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING, Substantially Equivalent on 1994-10-04. Applicant: Quantimetrix Corp.. Device class: 1.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1994-08-12
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

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