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510(k) K802319

Device
HEMOTEMP TM
Applicant
MARION LABORATORIES, INC.
510(k) number
K802319
Product code
KSE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-10
Date received
1980-09-23
Regulation
864.9700
Classification name
Refrigerator, Freezer, Blood Storage
Medical specialty
Hematology
Review panel
Hematology
Device class
2
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 KSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884436MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85Harris Mfg. Co.1988-12-02
K813327SEPCOR TEMPERATURE MONITORSeparation Science Corp.1981-12-31
K800667MONITEMP BLOOD PACK TEMP. MONITORLiquid Crystal Products, Inc.1980-04-16

Legacy Summary#

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FDA Review#

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