ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

Reagents, Test, Tetrahydrocannabinol

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/opi/coc/amp/bzo/bar/tca/pcp, Biosign Doa 8, Biosign Thc/opi/coc/amp/p.

Pre-market Notification Details

Device IDK983147
510k NumberK983147
Device Name:ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
ClassificationReagents, Test, Tetrahydrocannabinol
Applicant PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton,  NJ  08543 -7139
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton,  NJ  08543 -7139
Product CodeDKE  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJG
Subsequent Product CodeDKN
Subsequent Product CodeDKZ
Subsequent Product CodeLCM
Subsequent Product CodeLFI
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-08
Decision Date1998-09-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768001321 K983147 000

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