FDA.reportPublic FDA data

510(k) K912647

Device
Ise/ci-
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K912647
Product code
CGZ
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-17
Date received
1991-06-17
Regulation
862.1170
Classification name
Electrode, Ion-Specific, Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN D STEVENS
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K060108COBAS INTEGRA CHLORIDE ELCTRODE GEN.2Roche Diagnostics Corp.2006-02-16
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K003664DELFIA NEONATAL IRT KIT, MODEL A005-110Wallac OY2001-02-14
K003668AUTODELFIA NEONATAL IRT KIT, MODEL B005-112Wallac OY2001-02-12
K993697DELFIA NEONATAL IRT KITWallac OY2000-06-09
K000926EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMedica Corp.2000-05-15
K991870ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03A.P. Total Care, Inc.1999-07-30