Atlas FDA

KRZ

25 FDA 510(k) clearances · Product code

63 daysmedian time to decision
148 days90th percentile
25clearances measured

FDA profile

Official device name
Calibrator For Hemoglobin And Hematocrit Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8165
Medical specialty
Hematology
Adverse events (MAUDE)
2006: 16 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101)Roche Diagnostics2005-08-26
CDS HEMATOLOGY CALIBRATOR (CDS CAL) (K041130)Clinical Diagnostic Solutions, Inc.2004-06-10
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (K962864)Alko Diagnostic Corp.1996-12-18
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (K951071)Alko Diagnostic Corp.1995-07-24
CELL-DYN CALIBRATOR (K902892)Unipath , Ltd.1990-09-10
RAICHEM TM HEMOGLOBIN CALIBRATOR (K896921)Reagents Applications, Inc.1990-01-25
HGB-CAL SET/MULTIPLE (K893984)R&D Systems, Inc.1989-08-15
MSI-CAL 16 (K883850)Medical Specialties, Inc.1988-11-22
MSI-CAL 7 (K883703)Medical Specialties, Inc.1988-11-22
MSI-CAL 8 (K883851)Medical Specialties, Inc.1988-11-22
HEMOCUE HEMOGLOBIN CALIBRATOR (K882600)React and Co.1988-07-18
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (K873832)In Vitro Diagnostics, Inc.1987-11-23
CYANMETHEMOGLOBIN STANDARD (K871283)U. S. Diagnostics, Inc.1987-04-15
HEMATOLOGY CALIBRATOR CONTROL (K854166)Interscience Diagnostics, Inc.1986-03-12
LIQUI-HEME HEMOGLOBIN CALIBRATORS (K842668)Biodiagnostic Intl1985-03-05
QCA HEMOGLOBIN KIT (K843695)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-17
DADE HEMATOLOGY CALIBRATOR PLUS (K840010)American Dade1984-04-19
CAL-CHEX, A HEMATOLOGY CALIBRATOR (K840261)Streck Laboratories, Inc.1984-02-21
CALIBRATION STANDARD-HEMOGLOBIN (K831814)United Diagnostics, Inc.1983-07-28
CALIBRATOR 282 (K831872)Bionostics, Inc.1983-07-18
HEMACAL (K831306)Hematology Marketing Assoc.1983-06-16
CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT (K822327)Interscience, Inc.1982-11-16
SERALYZER HEMOGLOBIN CALIBRATORS (K822046)Miles Laboratories, Inc.1982-07-30
HEMESPEC CHECK SET (K800852)Helena Laboratories1980-05-02
SANDARE CYANMETHEMOGLOBIN STANDARD (K792358)Sandare Chemical Co., Inc.1979-12-31

Track KRZ automatically

Every clearance here is in the API, with alerts when new ones post.