Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-