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510(k) K974396

Device
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
Applicant
DIAMETRICS MEDICAL, INC.
510(k) number
K974396
Product code
CHL  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-18
Date received
1997-11-21
Regulation
862.1120
Classification name
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEVE BOEH
Address
2658 Patton Rd. Roseville MN US 55113 55113

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-04-09
K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.2020-03-27
K193246Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2020-01-24
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Legacy Summary#

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FDA Review#

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