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510(k) K981801

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA by Princeton BioMeditech Corp. — Product Code LFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1998
Date Received
May 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

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  • K961393 — TRICYCLICS SERUM TOX ASSAY (June 12, 1996)
  • K953761 — AXSYM TRICYCLIC ANTIDEPRESSANTS (November 22, 1995)