Cleared Traditional

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

K090940 · Astoria-Pacific, Inc. · Chemistry
Dec 2009
Decision
255d
Days
Class 1
Risk

About This 510(k) Submission

K090940 is an FDA 510(k) clearance for the SPOTCHECK BLOOD SPOT CONTROL, ASSAYED, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on December 14, 2009, 255 days after receiving the submission on April 3, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K090940 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2009
Decision Date December 14, 2009
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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