KRZ · Calibrator For Hemoglobin And Hematocrit Measurement
Hematology · 21 CFR 864.8165 · Class 2
Overview
| Product Code | KRZ |
|---|---|
| Device Name | Calibrator For Hemoglobin And Hematocrit Measurement |
| Regulation | 21 CFR 864.8165 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052101 | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | Roche Diagnostics | Aug 26, 2005 | SESE |
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | Jun 10, 2004 | SESE |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | Dec 18, 1996 | SESE |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Alko Diagnostic Corp. | Jul 24, 1995 | SESE |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | Sep 10, 1990 | SESE |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | Jan 25, 1990 | SESE |
| K893984 | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | Aug 15, 1989 | SESE |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | Nov 22, 1988 | SESE |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | Nov 22, 1988 | SESE |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | Nov 22, 1988 | SESE |
| K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | Jul 18, 1988 | SESE |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | Nov 23, 1987 | SESE |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | Apr 15, 1987 | SESE |
| K854166 | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | Mar 12, 1986 | SESE |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | Mar 5, 1985 | SESE |
| K843695 | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 17, 1984 | SESE |
| K840010 | DADE HEMATOLOGY CALIBRATOR PLUS | American Dade | Apr 19, 1984 | SESE |
| K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR | Streck Laboratories, Inc. | Feb 21, 1984 | SESE |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | United Diagnostics, Inc. | Jul 28, 1983 | SESE |
| K831872 | CALIBRATOR 282 | Bionostics, Inc. | Jul 18, 1983 | SESE |
Top Applicants
- Medical Specialties, Inc. — 3 clearances
- Alko Diagnostic Corp. — 2 clearances
- American Dade — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biodiagnostic Intl — 1 clearance
