Cleared Traditional

ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE

K950803 · Isolab, Inc. · Chemistry
Sep 1995
Decision
212d
Days
Class 1
Risk

About This 510(k) Submission

K950803 is an FDA 510(k) clearance for the ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on September 21, 1995, 212 days after receiving the submission on February 21, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K950803 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1995
Decision Date September 21, 1995
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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