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510(k) K823124

Device
IMS HEMATOLOGY MIXER
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
510(k) number
K823124
Product code
GLE  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-22
Date received
1982-10-22
Regulation
862.2050
Classification name
Mixer, Blood Tube
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
1
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 GLE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800003CORTEX DOUBLE HELIX SAMPLERCortex Research Corp.1980-02-01
K780544DISC-PAK ROTATORTechhnilab Instruments, Inc.1978-04-24
K771617SPECI-MIXThermolyne Corp.1977-09-02
K770830PLATELET AGITATORHelmer Labs, Inc.1977-07-11

Legacy Summary#

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FDA Review#

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