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510(k) K200865

Device
Piccolo Potassium Test System
Applicant
Abaxis, Inc.
510(k) number
K200865
Product code
MZV  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-20
Date received
2020-04-01
Regulation
862.1600
Classification name
Test, System, Potassium, Enzymatic Method
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dennis M Bleile
Address
3240 Whipple Rd. Union City CA US 94587 94587

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MZV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091455DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CALDiazyme Laboratories2009-08-14
K053566MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113ADiazyme Laboratories2006-02-15
K042191DIAZYME POTASSIUM ENZYMATIC ASSAY KITDiazyme Laboratories2004-10-29

Legacy Summary#

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FDA Review#

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