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510(k) K790027

Device
SHAKER, MODEL SH-510
Applicant
SYSMEX CORP.
510(k) number
K790027
Product code
JRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1979-02-08
Date received
1979-01-03
Regulation
862.2050
Classification name
Shaker/stirrer
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
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 JRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813318MINI-SHAKERDynatech Corp.1981-12-17
K813148S/P VORTEX MIXERAmerican Dade1981-11-24
K813149S/P VORTEX MIXER JR.American Dade1981-11-24
K801145SMI MULTI-TUBE VORTEXERScientific Manufacturing Industries1980-06-09
K790753DIMENSIONALL ROTATORAmerican Hospital Supply Corp.1979-06-28
K780543THERMAJUST CIRCU-TEMPTechhnilab Instruments, Inc.1978-05-26
K770165MICRO-MIX PIPETTE SHAKERMaddak, Inc.1977-01-31

Legacy Summary#

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FDA Review#

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