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510(k) K150791

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) by Healgen Scientific, LLC — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
March 25, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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