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510(k) K863438

Device
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
Applicant
NOVA BIOMEDICAL CORP.
510(k) number
K863438
Product code
JJP  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-29
Date received
1986-09-05
Regulation
862.2050
Classification name
Electrode, Ion Selective (non-specified)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL W MACDONALD
Address
200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900280CENTRIPREP 100Amicon, Inc.1990-02-16
K860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEReagent Laboratory, Inc.1986-02-10

Legacy Summary#

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FDA Review#

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