Product code KRZ— Hematology
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
- Classification name
- Calibrator For Hemoglobin And Hematocrit Measurement
- Device class
- Class 2
- Regulation
- 21 CFR 864.8165
- Advisory panel
- Hematology
- Total cleared
- 25
- First cleared
- Most recent
Market context for product code KRZ
FDA has cleared devices under product code KRZ between 1979 and 2005, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2005
- 2004
- 1996
- 1995
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1980
- 1979
Top applicants under product code KRZ
Recent clearances under product code KRZ
- K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
- K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)
- K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
- K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
- K902892 — CELL-DYN CALIBRATOR
- K896921 — RAICHEM TM HEMOGLOBIN CALIBRATOR
- K893984 — HGB-CAL SET/MULTIPLE
- K883703 — MSI-CAL 7
- K883850 — MSI-CAL 16
- K883851 — MSI-CAL 8
- K882600 — HEMOCUE HEMOGLOBIN CALIBRATOR
- K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
- K871283 — CYANMETHEMOGLOBIN STANDARD
- K854166 — HEMATOLOGY CALIBRATOR CONTROL
- K842668 — LIQUI-HEME HEMOGLOBIN CALIBRATORS
- K843695 — QCA HEMOGLOBIN KIT
- K840010 — DADE HEMATOLOGY CALIBRATOR PLUS
- K840261 — CAL-CHEX, A HEMATOLOGY CALIBRATOR
- K831814 — CALIBRATION STANDARD-HEMOGLOBIN
- K831872 — CALIBRATOR 282
- K831306 — HEMACAL
- K822327 — CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT
- K822046 — SERALYZER HEMOGLOBIN CALIBRATORS
- K800852 — HEMESPEC CHECK SET
- K792358 — SANDARE CYANMETHEMOGLOBIN STANDARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.