FDA Product Code
FDA Product Code KRZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8165
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052101 | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | Roche Diagnostics | 2005-08-26 | Abbreviated | PDF ↗ |
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 | Abbreviated | PDF ↗ |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | 1996-12-18 | Traditional | PDF ↗ |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Alko Diagnostic Corp. | 1995-07-24 | Traditional | PDF ↗ |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | 1990-09-10 | Traditional | PDF ↗ |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | 1990-01-25 | Traditional | PDF ↗ |
| K893984 | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | 1988-07-18 | Traditional | PDF ↗ |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | 1987-04-15 | Traditional | PDF ↗ |
| K854166 | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | 1985-03-05 | Traditional | PDF ↗ |
| K843695 | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-17 | Traditional | PDF ↗ |
| K840010 | DADE HEMATOLOGY CALIBRATOR PLUS | American Dade | 1984-04-19 | Traditional | PDF ↗ |
| K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR | Streck Laboratories, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | United Diagnostics, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K831872 | CALIBRATOR 282 | Bionostics, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K831306 | HEMACAL | Hematology Marketing Assoc. | 1983-06-16 | Traditional | PDF ↗ |
| K822327 | CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT | Interscience, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K822046 | SERALYZER HEMOGLOBIN CALIBRATORS | Miles Laboratories, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K800852 | HEMESPEC CHECK SET | Helena Laboratories | 1980-05-02 | Traditional | PDF ↗ |
| K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD | Sandare Chemical Co., Inc. | 1979-12-31 | Traditional | PDF ↗ |
Product code KRZ · Class II · Hematology. Data: openFDA.