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510(k) K042988

RAPID ONE STEP BUPRENORPHINE TEST CARD by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2005
Date Received
October 29, 2004
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

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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)
  • K042990 — FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (May 10, 2005)

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