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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 K962521
Device Name FACTPLUS ONE STEP PREGNANCY TEST
Applicant
DIRECT ACCESS DIAGNOSTICS
440 RT. 22 EAST
BRIDGEWATER,  NJ  08807
Applicant Contact MARYLOU PANICO
Correspondent
DIRECT ACCESS DIAGNOSTICS
440 RT. 22 EAST
BRIDGEWATER,  NJ  08807
Correspondent Contact MARYLOU PANICO
Regulation Number862.1155
Classification Product Code
LCX  
Date Received06/19/1996
Decision Date 07/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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