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510(k) K130275

QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
February 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Tianjin New Bay Bioresearch Co., Ltd.

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  • K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST (September 24, 2012)
  • K071489 — HOMECHECK MULTIPLE DRUG CUP TEST (March 28, 2008)
  • K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HO (January 14, 2008)
  • K061617 — FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (November 22, 2006)
  • K052520 — RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMIN (April 24, 2006)
  • 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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