Cleared Traditional

SENTINEL PANCREATIC AMYLASE

K051447 · Sentinel Ch. Srl · Chemistry
Jan 2006
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K051447 is an FDA 510(k) clearance for the SENTINEL PANCREATIC AMYLASE, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on January 26, 2006, 238 days after receiving the submission on June 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K051447 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date January 26, 2006
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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