Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8165](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8165) → KRZ — Calibrator For Hemoglobin And Hematocrit Measurement # KRZ · Calibrator For Hemoglobin And Hematocrit Measurement _Hematology · 21 CFR 864.8165 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ ## Overview - **Product Code:** KRZ - **Device Name:** Calibrator For Hemoglobin And Hematocrit Measurement - **Regulation:** [21 CFR 864.8165](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8165) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## 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](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K052101.md) | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | Roche Diagnostics | Aug 26, 2005 | SESE | | [K041130](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K041130.md) | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | Jun 10, 2004 | SESE | | [K962864](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K962864.md) | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | Dec 18, 1996 | SESE | | [K951071](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K951071.md) | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Alko Diagnostic Corp. | Jul 24, 1995 | SESE | | [K902892](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K902892.md) | CELL-DYN CALIBRATOR | Unipath , Ltd. | Sep 10, 1990 | SESE | | [K896921](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K896921.md) | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | Jan 25, 1990 | SESE | | [K893984](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K893984.md) | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | Aug 15, 1989 | SESE | | [K883851](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K883851.md) | MSI-CAL 8 | Medical Specialties, Inc. | Nov 22, 1988 | SESE | | [K883850](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K883850.md) | MSI-CAL 16 | Medical Specialties, Inc. | Nov 22, 1988 | SESE | | [K883703](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K883703.md) | MSI-CAL 7 | Medical Specialties, Inc. | Nov 22, 1988 | SESE | | [K882600](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K882600.md) | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | Jul 18, 1988 | SESE | | [K873832](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K873832.md) | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | Nov 23, 1987 | SESE | | [K871283](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K871283.md) | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | Apr 15, 1987 | SESE | | [K854166](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K854166.md) | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | Mar 12, 1986 | SESE | | [K842668](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K842668.md) | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | Mar 5, 1985 | SESE | | [K843695](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K843695.md) | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 17, 1984 | SESE | | [K840010](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K840010.md) | DADE HEMATOLOGY CALIBRATOR PLUS | American Dade | Apr 19, 1984 | SESE | | [K840261](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K840261.md) | CAL-CHEX, A HEMATOLOGY CALIBRATOR | Streck Laboratories, Inc. | Feb 21, 1984 | SESE | | [K831814](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K831814.md) | CALIBRATION STANDARD-HEMOGLOBIN | United Diagnostics, Inc. | Jul 28, 1983 | SESE | | [K831872](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K831872.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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