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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K921421
Device Name LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
Applicant
Pro-Lab, Inc.
76 Glengarry Ave.
Toronto
Ontario Canada M5m 1c9,  CA
Applicant Contact JOACHIM SPARKUHL
Correspondent
Pro-Lab, Inc.
76 Glengarry Ave.
Toronto
Ontario Canada M5m 1c9,  CA
Correspondent Contact JOACHIM SPARKUHL
Regulation Number866.3300
Classification Product Code
LHL  
Date Received03/24/1992
Decision Date 07/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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