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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K920716
Device Name DIRECT PREGNANCY TEST
Applicant
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact CHEN
Correspondent
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact CHEN
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received02/18/1992
Decision Date 03/24/1992
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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