Automated Cell-washing Centrifuge For Immune-hematology

Centrifuge, Cell-washing, Automated For Immuno-hematology

Micro Typing Systems Inc.

The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.

Pre-market Notification Details

Device IDBK920014
510k NumberBK920014
Device Name:Automated Cell-washing Centrifuge For Immune-hematology
ClassificationCentrifuge, Cell-washing, Automated For Immuno-hematology
Applicant Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach,  FL  33069
Product CodeKSN  
CFR Regulation Number864.9285 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-07
Decision Date1993-09-29

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