FDA product code KRZ: Calibrator For Hemoglobin And Hematocrit Measurement
KRZ is the FDA product code for calibrator for hemoglobin and hematocrit measurement. It is a Class II device, regulated under 21 CFR 864.8165 and reviewed by the Hematology panel. FDA has cleared 25 510(k) submissions under KRZ, from 22 different applicants. The average 510(k) review took 74 days (median 63). FDA has posted 2 recalls for KRZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator For Hemoglobin And Hematocrit Measurement |
| Device class | Class II |
| Regulation | 21 CFR 864.8165 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KRZ clearance
Top KRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Specialties, Inc. | 3 | 1988-11-22 |
| Alko Diagnostic Corp. | 2 | 1996-12-18 |
| Roche Diagnostics | 1 | 2005-08-26 |
| Clinical Diagnostic Solutions, Inc. | 1 | 2004-06-10 |
| Unipath , Ltd. | 1 | 1990-09-10 |
17 more applicants have KRZ clearances. See the full list in Caduvo.
Most recent KRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052101 | Roche Diagnostics | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | 2005-08-26 | 23 |
| K041130 | Clinical Diagnostic Solutions, Inc. | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | 2004-06-10 | 41 |
| K962864 | Alko Diagnostic Corp. | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | 1996-12-18 | 148 |
| K951071 | Alko Diagnostic Corp. | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | 1995-07-24 | 138 |
| K902892 | Unipath , Ltd. | CELL-DYN CALIBRATOR | 1990-09-10 | 70 |
Recalls for KRZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-04.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code KRZ?
KRZ is the FDA product code for calibrator for hemoglobin and hematocrit measurement. It is a Class II device, regulated under 21 CFR 864.8165 and reviewed by the Hematology panel.
What device class is KRZ?
Class II, regulation 21 CFR 864.8165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KRZ?
Across 25 cleared submissions the average was 74 days from receipt to decision (median 63).
Which companies have the most KRZ clearances?
Medical Specialties, Inc. (3); Alko Diagnostic Corp. (2); Roche Diagnostics (1); Clinical Diagnostic Solutions, Inc. (1); Unipath , Ltd. (1).
Have KRZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KRZ
- Run a recall and safety report across every KRZ manufacturer
- Watch product code KRZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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