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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 K831366
Device Name TESTCORP PREG
Applicant
CATHETER TECHNOLOGY CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CATHETER TECHNOLOGY CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received04/26/1983
Decision Date 06/02/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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