FDA Product Code KRZ: Calibrator For Hemoglobin And Hematocrit Measurement
Leading manufacturers include Medical Specialties, Inc., Alko Diagnostic Corp. and Bionostics, Inc..
25
Total
25
Cleared
74d
Avg days
1979
Since
FDA 510(k) Cleared Calibrator For Hemoglobin And Hematocrit Measurement Devices (Product Code KRZ)
25 devices
Cleared
Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
Roche Diagnostics
Chemistry
23d
Cleared
Dec 18, 1996
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
Alko Diagnostic Corp.
Hematology
148d
Cleared
Jul 24, 1995
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
Alko Diagnostic Corp.
Hematology
138d
Cleared
Sep 10, 1990
CELL-DYN CALIBRATOR
Unipath , Ltd.
Hematology
70d
Cleared
Jan 25, 1990
RAICHEM TM HEMOGLOBIN CALIBRATOR
Reagents Applications, Inc.
Hematology
45d
Cleared
Aug 15, 1989
HGB-CAL SET/MULTIPLE
R&D Systems, Inc.
Hematology
71d
Cleared
Nov 22, 1988
MSI-CAL 7
Medical Specialties, Inc.
Hematology
84d
Cleared
Nov 22, 1988
MSI-CAL 16
Medical Specialties, Inc.
Hematology
84d
Cleared
Nov 22, 1988
MSI-CAL 8
Medical Specialties, Inc.
Hematology
84d
Cleared
Dec 17, 1984
QCA HEMOGLOBIN KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology
89d
Cleared
Apr 19, 1984
DADE HEMATOLOGY CALIBRATOR PLUS
American Dade
Hematology
106d
Cleared
Feb 21, 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
Streck Laboratories, Inc.
Hematology
47d
Cleared
Jul 18, 1983
CALIBRATOR 282
Bionostics, Inc.
Hematology
35d
Cleared
Jul 30, 1982
SERALYZER HEMOGLOBIN CALIBRATORS
Miles Laboratories, Inc.
Hematology
18d
Cleared
May 02, 1980
HEMESPEC CHECK SET
Helena Laboratories
Hematology
17d