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510(k) K890721

Device
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
Applicant
ACTIO, INC.
510(k) number
K890721
Product code
DIE  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-10
Date received
1989-02-13
Regulation
862.3280
Classification name
Heavy Metals Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEWIN, PH.D.
Address
1127-57th Ave. Oakland CA US 94621 94621

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DIE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020610LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529Bio-Rad2002-04-22
K990928LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405Bio-Rad1999-04-16
K891691LYPHOCHEK URINE METALS CONTROL, LEVELS I AND IIBio-Rad1989-12-19
K863915SHAPE-ACTIO METAL TOXICOLOGY CONTROLShape Products Co.1986-11-24

Legacy Summary#

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FDA Review#

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