D-CHEM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

PHOTEC DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem.

Pre-market Notification Details

Device IDK882307
510k NumberK882307
Device Name:D-CHEM
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
ContactBarry Mcdonald
CorrespondentBarry Mcdonald
PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls,  NJ  07424
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-03
Decision Date1988-08-02

Trademark Results [D-CHEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
D-CHEM
D-CHEM
73765566 1552672 Dead/Cancelled
PHOTEST DIAGNOSTICS, INC.
1988-11-25

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