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510(k) K153050

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard by Co-Innovation Biotech Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2016
Date Received
October 20, 2015
Clearance Type
Special
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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  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K131110 — ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPC (January 15, 2014)
  • K132085 — ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM (November 12, 2013)

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