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510(k) K781874

Device
MYCOPLASMA ARGININI FITC (30-403-41)
Applicant
FLOW LABORATORIES, INC.
510(k) number
K781874
Product code
KPB  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-20
Date received
1978-11-03
Regulation
864.2360
Classification name
Media And Components, Mycoplasma Detection
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

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 KPB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781875STAIN KIT FOR CELL CULTURES (30-100-00)Flow Laboratories, Inc.1978-12-20
K781390MYCOPLASMA HYORHINIS (BTS-7)Flow Laboratories, Inc.1978-09-01
K771867MYCOPLASMA DETECTION KITBioassay Systems Research Corp.1977-11-17

Legacy Summary#

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FDA Review#

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