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510(k) K071489

HOMECHECK MULTIPLE DRUG CUP TEST by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2008
Date Received
May 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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

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  • 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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