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510(k) K822716

Device
UNIVERSAL CENTRIFUGE
Applicant
BIODYNAMICS CORP.
510(k) number
K822716
Product code
JPI  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-30
Date received
1982-09-07
Regulation
864.6400
Classification name
Device, Hematocrit Measuring
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JPI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-28
K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories2017-08-22
K950942CRIT-LINE HEMATOCRIT ALERTIn-Line Diagnostics Corp.1995-03-14
K924167CRIT-LINENoninvasive Medical Technology Corp.1993-05-07
K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin Technologies1990-09-17
K902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, Inc.1990-06-20
K870511CHART-TYPE MICRO HEMATOCRIT TUBE READERNorfolk Scientific, Inc.1987-03-16
K852482MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94Em Diagnostic Systems, Inc.1985-07-15
K852516CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINEWhittaker General Medical1985-07-15
K850391PLASMA EXTRACTION SYSTEMHans J. Brouwers & Assoc.1985-05-10
K840767HAEMOFUGE A. BIOFUGE A. & BHeraeus-Christ GmbH1984-04-17
K831318COMPUR* M1100 HEMATRCRIT SYSTEMWorthington Diagnostic Systems1983-06-08
K830578MICROHEMATOCRIT READERFisher Scientific Co., LLC1983-03-24
K823558MICRO-HEMATOCRIT CENTRIFUGE 335/336Fisher Scientific Co., LLC1983-01-21

Legacy Summary#

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FDA Review#

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