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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K864659
Device Name BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
Applicant
Bio Mega Diagnostic, Inc.
10900, Rue Hamon
Montreal, (Quebec)
Canada,  CA H3M 3A2
Applicant Contact LOUIS-DANIEL LEVAC
Correspondent
Bio Mega Diagnostic, Inc.
10900, Rue Hamon
Montreal, (Quebec)
Canada,  CA H3M 3A2
Correspondent Contact LOUIS-DANIEL LEVAC
Regulation Number862.1690
Classification Product Code
JLW  
Date Received11/28/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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