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510(k) K772105

Device
PLATELET KIT
Applicant
STRECK LABORATORIES, INC.
510(k) number
K772105
Product code
GLG  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-30
Date received
1977-11-07
Regulation
864.6160
Classification name
Platelet Counting, Manual
Medical specialty
Hematology
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 GLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842921REES & ECKER DILUTION FLUIDE K Ind., Inc.1984-09-07
K811084LABTRONIX PLATELET COUNTER(L/O/C.)Labtronix Corp.1981-07-23

Legacy Summary#

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FDA Review#

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