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Panels › Hematology › Product code KRZ · Class 2

Calibrator For Hemoglobin And Hematocrit Measurement

Regulation 864.8165

0510(k)s in 12 months (25 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in KRZ

Company510(k)sRecalls
Medical Specialties, Inc.30
Alko Diagnostic Corp.20
American Dade10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Bio-Rad Laboratories, Inc.01
Biodiagnostic Intl10
Bionostics, Inc.10
Clinical Diagnostic Solutions, Inc.10
Helena Laboratories10
Hematology Marketing Assoc.10
DateFirm and productCodeLinked 510(k)
Jul 3, 2025Siemens Healthcare Diagnostics, Inc.
ADVIA 120/2120/2120i SETpoint Calibrator
Open, Classified		 KRZK840261
Jan 11, 2012Bio-Rad Laboratories, Inc.
VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100
Terminated		 KRZK070819

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