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510(k) K831195

Device
WESTERGREN DISPETTE FOR ESR
Applicant
ULSTER SCIENTIFIC, INC.
510(k) number
K831195
Product code
JPH  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-09
Date received
1983-04-12
Regulation
864.6700
Classification name
Test, Erythrocyte Sedimentation Rate
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 JPH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871076WINPETTEUlster Scientific, Inc.1987-03-23
K860899DISPETTE IIUlster Scientific, Inc.1986-04-14
K852554SRT-SYSTEMMicrowave Development, Inc.1985-07-18
K840500SEDIPLASTPrecision Technology, Inc.1984-02-21
K823761ERYTHROCYTE & STAND SEDIMENT. RATE TUBECordis Corp.1983-01-21
K823368DADE ESR KITAmerican Dade1982-12-28

Legacy Summary#

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FDA Review#

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