FDA 510(K) K142754, Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
FDA 510(K) K142754, Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K142754
Device Name Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Applicant Sugentech, Inc.
Regulation Number 862.1155
Classification Product Code LCX
Date Received 09/25/2014
Decision Date 04/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
Total pages: 1425
Fully redacted pages: 1208
Content pages: 217
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