Cleared Special

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

K042442 · Orion Diagnostica, OY · Chemistry

Sep 2004

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K042442 is an FDA 510(k) clearance for the QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on September 24, 2004, 15 days after receiving the submission on September 9, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K042442 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2004
Decision Date	September 24, 2004
Days to Decision	15 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Statement