Cleared Traditional

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL

K111363 · Medica Corp. · Chemistry
Dec 2011
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K111363 is an FDA 510(k) clearance for the PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on December 6, 2011, 204 days after receiving the submission on May 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K111363 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2011
Decision Date December 06, 2011
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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