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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 K854104
Device Name IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
Applicant
Immunchem Corp.
20770 Leapwood Ave.
Carson,  CA  90746
Applicant Contact BOB HUDAK
Correspondent
Immunchem Corp.
20770 Leapwood Ave.
Carson,  CA  90746
Correspondent Contact BOB HUDAK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/08/1985
Decision Date 12/05/1985
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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