Cleared Traditional

N-ASSAY GLU-UL

K980883 · Crestat Diagnostics, Inc. · Chemistry
Sep 1998
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K980883 is an FDA 510(k) clearance for the N-ASSAY GLU-UL, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Crestat Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on September 3, 1998, 178 days after receiving the submission on March 9, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K980883 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1998
Decision Date September 03, 1998
Days to Decision 178 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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