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510(k) K112449

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST by Tianjin New Bay Bioresearch Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2012
Date Received
August 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K052882 — FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (February 15, 2006)
  • K052208 — GLUCOSE PILOT (December 9, 2005)
  • K042988 — RAPID ONE STEP BUPRENORPHINE TEST CARD (May 12, 2005)
  • K042990 — FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (May 10, 2005)

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