Cleared Traditional

EYE SPOT CRP TEST

K932180 · J.S. Medical Assoc. · Immunology
Aug 1993
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K932180 is an FDA 510(k) clearance for the EYE SPOT CRP TEST, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on August 23, 1993, 110 days after receiving the submission on May 5, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K932180 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1993
Decision Date August 23, 1993
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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