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510(k) K790815

Device
CULTURETTE BRAND PVA
Applicant
MARION LABORATORIES, INC.
510(k) number
K790815
Product code
IGM  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-15
Date received
1979-04-27
Regulation
864.4010
Classification name
Solution, Carnoy's
Medical specialty
Pathology
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IGM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842737CARNOY'S SOLUTIONE K Ind., Inc.1984-09-07
K822126VOLU-SOL CARNOY FLUIDVolu Sol Medical Industries1982-08-05

Legacy Summary#

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FDA Review#

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