Cleared Traditional

EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT

K080823 · Medica Corp. · Chemistry
Nov 2008
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K080823 is an FDA 510(k) clearance for the EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 17, 2008, 238 days after receiving the submission on March 24, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K080823 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2008
Decision Date November 17, 2008
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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