Cleared Traditional

SPQ TM TEST SYSTEM II FOR CRP

K892526 · Atlantic Antibodies · Immunology
May 1989
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K892526 is an FDA 510(k) clearance for the SPQ TM TEST SYSTEM II FOR CRP, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on May 9, 1989, 28 days after receiving the submission on April 11, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K892526 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 09, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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