Cleared Traditional

C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

K002651 · Pointe Scientific, Inc., · Chemistry
Oct 2000
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K002651 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 13, 2000, 49 days after receiving the submission on August 25, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K002651 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2000
Decision Date October 13, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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