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510(k) K852136

Device
Precinorm Hb
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K852136
Product code
GGM
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-05
Date received
1985-05-16
Regulation
864.8625
Classification name
Control, Hemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUE SMITH
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k)DeviceApplicantDecision date
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K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.2019-02-01
K070546LYPHOCHEK DIABETES CONTROLBio-Rad Laboratories2007-04-02
K070334R&D SICKLE QC CONTROLR&D Systems, Inc.2007-03-29
K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4Bio-Rad2005-11-09
K032791GLYCOHEMOSURE HBA1C CONTROLQuantimetrix Corp.2003-10-30
K003030LYPHOCHEK HEMOGLOBIN ALC LINEARITY SETBio-Rad2000-11-29
K993321R&D HGB/GLC WHOLE BLOOD CONTROLR&D Systems, Inc.1999-11-12
K964052HEMOCUE HEMOTROLDirect Solutions1996-11-06
K963908HEMOCUE HEMOLINDirect Solutions1996-10-16
K921681CRITERION, HEMOCUE B-HEMOGLOBIN CONTROLIsolab, Inc.1992-11-17
K893985HGB-CONTROL SET/MULTIPLER&D Systems, Inc.1989-08-15
K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3Dade, Baxter Travenol Diagnostics, Inc.1980-03-05
K790310HEMOGLOBIN CONTROLSElectrophoresis Corp.1979-03-21