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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 K953486
Device Name MIT ONE STEP PREGNANCY TEST
Applicant
3C DIAGNOSTICS, INC.
411 KWAN FU ROAD
SEC. 1
hsin chu, r.o.c.,  TW
Applicant Contact z eigner
Correspondent
3C DIAGNOSTICS, INC.
411 KWAN FU ROAD
SEC. 1
hsin chu, r.o.c.,  TW
Correspondent Contact z eigner
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/25/1995
Decision Date 12/21/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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