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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K861946
Device Name PTK PLUS. HOME PREGNANCY TEST
Applicant
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Applicant Contact BALZER, JR
Correspondent
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Correspondent Contact BALZER, JR
Regulation Number862.1155
Classification Product Code
LCX  
Date Received05/20/1986
Decision Date 06/16/1986
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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