MICROHEMATOCRIT ROTOR

Centrifuge, Hematocrit

FISHER SCIENTIFIC CO., LLC.

The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Microhematocrit Rotor.

Pre-market Notification Details

Device IDK930415
510k NumberK930415
Device Name:MICROHEMATOCRIT ROTOR
ClassificationCentrifuge, Hematocrit
Applicant FISHER SCIENTIFIC CO., LLC. 711 FORBES AVE. Pittsburgh,  PA  15219
ContactDonna Chesna
CorrespondentDonna Chesna
FISHER SCIENTIFIC CO., LLC. 711 FORBES AVE. Pittsburgh,  PA  15219
Product CodeGKG  
CFR Regulation Number864.6400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-26
Decision Date1993-03-23

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