Cleared Traditional

AMYLASE (KINETIC) REAGENT SET

K915704 · Tech Intl. Co. · Chemistry
Jun 1996
Decision
1675d
Days
Class 2
Risk

About This 510(k) Submission

K915704 is an FDA 510(k) clearance for the AMYLASE (KINETIC) REAGENT SET, a Nitrosalicylate Reduction, Amylase (Class II — Special Controls, product code CJD), submitted by Tech Intl. Co. (Placentia, US). The FDA issued a Cleared decision on June 28, 1996, 1675 days after receiving the submission on November 27, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K915704 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1991
Decision Date June 28, 1996
Days to Decision 1675 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJD — Nitrosalicylate Reduction, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070