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510(k) K052520

RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2006
Date Received
September 14, 2005
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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  • 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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