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510(k) K953393

Device
TOX PERFECT A TUBE
Applicant
CHIMERA RESEARCH & CHEMICAL, INC.
510(k) number
K953393
Product code
DMP  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-06
Date received
1995-07-14
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHARLES A HAY
Address
P.O. Box 3363 Seminole FL US 33775 33775

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
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#

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FDA Review#

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