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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Parasite Concentration
510(k) Number K831365
Device Name TESTCORP ANA
Applicant
Catheter Technology Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Catheter Technology Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2900
Classification Product Code
LKS  
Date Received04/26/1983
Decision Date 06/02/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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