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510(k) K973973

Device
ELECSYS CALLCHECK DIGOXIN
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K973973
Product code
DMP  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-04
Date received
1997-10-20
Regulation
862.3280
Classification name
Digoxin Control Serum, Ria
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JODY J SAVAGE
Address
4300 Hacienda Dr. Pleasanton CA US 94588 94588

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953393TOX PERFECT A TUBEChimera Research & Chemical, Inc.1995-10-06
K780889DIGOXIN STANDARDS IN HUMAN SERUMPcl-Ria, Inc.1978-08-14
K770411DIGI TROL TM-RX & DIGI TROL TM-TXNuclear Medical Laboratories, Inc.1977-03-16

Legacy Summary#

summary

FDA Review#

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