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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 K862247
Device Name TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
Applicant
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Applicant Contact HERRANEN, PHD
Correspondent
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Correspondent Contact HERRANEN, PHD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received06/12/1986
Decision Date 07/29/1986
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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