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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 K923030
Device Name ANI BIOCARD HCG TEST
Applicant
ANI OY
81 FINCHDENE SQUARE, UNIT 1
SCARBOROUGH, ONTARIO,
CANADA M1X 1B4,  CA
Applicant Contact JEREMY CLAPP
Correspondent
ANI OY
81 FINCHDENE SQUARE, UNIT 1
SCARBOROUGH, ONTARIO,
CANADA M1X 1B4,  CA
Correspondent Contact JEREMY CLAPP
Regulation Number862.1155
Classification Product Code
JHI  
Date Received06/23/1992
Decision Date 09/15/1992
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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