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510(k) K800003

Device
CORTEX DOUBLE HELIX SAMPLER
Applicant
CORTEX RESEARCH CORP.
510(k) number
K800003
Product code
GLE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-01
Date received
1980-01-02
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K823124IMS HEMATOLOGY MIXERInnovative Medical Systems, Inc.1982-11-22
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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