Cleared Traditional

AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL

K951435 · Aalto Scientific, Ltd. · Chemistry
May 1995
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K951435 is an FDA 510(k) clearance for the AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Aalto Scientific, Ltd. (Vista, US). The FDA issued a Cleared decision on May 2, 1995, 36 days after receiving the submission on March 27, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K951435 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1995
Decision Date May 02, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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