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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 K882588
Device Name BLUE DOT(TM) TEST FOR PREGNANCY
Applicant
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Applicant Contact WILLA K BRUNKHORST
Correspondent
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Correspondent Contact WILLA K BRUNKHORST
Regulation Number862.1155
Classification Product Code
LCX  
Date Received06/23/1988
Decision Date 10/06/1988
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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