Cleared Traditional

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

K000556 · Elan Diagnostics · Chemistry
May 2000
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K000556 is an FDA 510(k) clearance for the ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on May 17, 2000, 89 days after receiving the submission on February 18, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K000556 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2000
Decision Date May 17, 2000
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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