KRZ — Calibrator For Hemoglobin And Hematocrit Measurement Class II
FDA product code KRZ covers "Calibrator For Hemoglobin And Hematocrit Measurement", a Class II medical device regulated under 21 CFR 864.8165. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRZ
- Device Class
- Class II
- Regulation Number
- 864.8165
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052101 | roche diagnostics | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | August 26, 2005 |
| K041130 | clinical diagnostic solutions | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | June 10, 2004 |
| K962864 | alko diagnostic | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | December 18, 1996 |
| K951071 | alko diagnostic | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | July 24, 1995 |
| K902892 | unipath | CELL-DYN CALIBRATOR | September 10, 1990 |
| K896921 | reagents applications | RAICHEM TM HEMOGLOBIN CALIBRATOR | January 25, 1990 |
| K893984 | r and d systems | HGB-CAL SET/MULTIPLE | August 15, 1989 |
| K883851 | medical specialties | MSI-CAL 8 | November 22, 1988 |
| K883703 | medical specialties | MSI-CAL 7 | November 22, 1988 |
| K883850 | medical specialties | MSI-CAL 16 | November 22, 1988 |
| K882600 | react and | HEMOCUE HEMOGLOBIN CALIBRATOR | July 18, 1988 |
| K873832 | in vitro diagnostics | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | November 23, 1987 |
| K871283 | u. s. diagnostics | CYANMETHEMOGLOBIN STANDARD | April 15, 1987 |
| K854166 | interscience diagnostics | HEMATOLOGY CALIBRATOR CONTROL | March 12, 1986 |
| K842668 | biodiagnostic intl | LIQUI-HEME HEMOGLOBIN CALIBRATORS | March 5, 1985 |
| K843695 | bd becton dickinson vacutainer systems preanalytic | QCA HEMOGLOBIN KIT | December 17, 1984 |
| K840010 | american dade | DADE HEMATOLOGY CALIBRATOR PLUS | April 19, 1984 |
| K840261 | streck laboratories | CAL-CHEX, A HEMATOLOGY CALIBRATOR | February 21, 1984 |
| K831814 | united diagnostics | CALIBRATION STANDARD-HEMOGLOBIN | July 28, 1983 |
| K831872 | bionostics | CALIBRATOR 282 | July 18, 1983 |