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510(k) K780889

Device
DIGOXIN STANDARDS IN HUMAN SERUM
Applicant
PCL-RIA, INC.
510(k) number
K780889
Product code
DMP  
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-14
Date received
1978-05-31
Regulation
862.3280
Classification name
Digoxin Control Serum, Ria
Medical specialty
Toxicology
Review panel
Toxicology
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 DMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973973ELECSYS CALLCHECK DIGOXINBoehringer Mannheim Corp.1997-11-04
K953393TOX PERFECT A TUBEChimera Research & Chemical, Inc.1995-10-06
K770411DIGI TROL TM-RX & DIGI TROL TM-TXNuclear Medical Laboratories, Inc.1977-03-16

Legacy Summary#

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FDA Review#

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