Cleared Traditional

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING

K943925 · Quantimetrix Corp. · Chemistry
Oct 1994
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K943925 is an FDA 510(k) clearance for the SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on October 4, 1994, 53 days after receiving the submission on August 12, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K943925 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1994
Decision Date October 04, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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