Cleared Traditional

DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM

K001767 · Diamedix Corp. · Microbiology
Aug 2000
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K001767 is an FDA 510(k) clearance for the DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 7, 2000, 56 days after receiving the submission on June 12, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K001767 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2000
Decision Date August 07, 2000
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJO — Antigen, Iha, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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