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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 Rd.
Sec. 1
Hsin Chu, R.O.C.,  TW
Applicant Contact Z EIGNER
Correspondent
3c Diagnostics, Inc.
411 Kwan Fu Rd.
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
Predetermined Change
Control Plan Authorized		 No
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