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510(k) K844589

Device
OSMOLARITY STANDARDS
Applicant
RNA MEDICAL CORP.
510(k) number
K844589
Product code
JMZ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-01
Date received
1984-11-26
Regulation
862.1540
Classification name
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ADOLPH E D'AMICO
Address
21 Cummings Park Suite 228 Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843680URI-VALCenogenics Corp.1985-03-29

Legacy Summary#

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FDA Review#

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