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510(k) K781062

Device
DROPPER, SOLUTION TRICHROME, CEPTI-SEAL
Applicant
MARION LABORATORIES, INC.
510(k) number
K781062
Product code
HYW  
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-14
Date received
1978-06-26
Regulation
864.1850
Classification name
Stain, Trichrome, Mallory's
Medical specialty
Hematology
Review panel
Clinical Chemistry
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 HYW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792706PARA-PAK(WHEATLEY'S TRICHROME STAIN)Meridian Diagnostics, Inc.1980-01-24

Legacy Summary#

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FDA Review#

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