SYSTEM 8000 CELL COUNTER

Counter, Cell, Automated (particle Counter)

BAKER INSTRUCTIONS CORP.

The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for System 8000 Cell Counter.

Pre-market Notification Details

Device IDK850386
510k NumberK850386
Device Name:SYSTEM 8000 CELL COUNTER
ClassificationCounter, Cell, Automated (particle Counter)
Applicant BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown,  PA  18001
ContactTomalesky
CorrespondentTomalesky
BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown,  PA  18001
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-01
Decision Date1985-05-02

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