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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K910349
Device Name IMMUNOCORP COATED TUBE IRMA HCG
Applicant
Immunocorp
5800 Royalmount
Montreal
Quebec, Canada,  CA H4P 1K5
Applicant Contact DU RUISSEAU
Correspondent
Immunocorp
5800 Royalmount
Montreal
Quebec, Canada,  CA H4P 1K5
Correspondent Contact DU RUISSEAU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received01/29/1991
Decision Date 03/21/1991
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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