510(k) K761304

Device
JTB 700 HEMATOLOGY ANALYZER
Applicant
J.T. Baker Chemical Co.
510(k) number
K761304
Product code
JPJ
Decision
Substantially Equivalent (SESE)
Decision date
1977-02-01
Date received
1976-12-22
Regulation
864.5300
Classification name
Red-Cell Indices, Calculated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JPJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904675QBC SYSTEM MCHCBd Becton Dickinson Vacutainer Systems Preanalytic1990-11-02
K780946ROYCO MODEL 970 HEMATOLOGY DATA ANALYZERHycel, Inc.1978-07-27