Product code KRZ
- Device name
- Calibrator For Hemoglobin And Hematocrit Measurement
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8165
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052101 | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | Roche Diagnostics | 2005-08-26 |
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | 1996-12-18 |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Alko Diagnostic Corp. | 1995-07-24 |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | 1990-09-10 |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | 1990-01-25 |
| K893984 | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | 1988-11-22 |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | 1988-11-22 |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | 1988-11-22 |
| K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | 1988-07-18 |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | 1987-11-23 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | 1987-04-15 |
| K854166 | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | 1986-03-12 |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | 1985-03-05 |
| K843695 | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-17 |
| K840010 | DADE HEMATOLOGY CALIBRATOR PLUS | American Dade | 1984-04-19 |
| K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR | Streck Laboratories, Inc. | 1984-02-21 |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | United Diagnostics, Inc. | 1983-07-28 |
| K831872 | CALIBRATOR 282 | Bionostics, Inc. | 1983-07-18 |
| K831306 | HEMACAL | Hematology Marketing Assoc. | 1983-06-16 |
| K822327 | CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT | Interscience, Inc. | 1982-11-16 |
| K822046 | SERALYZER HEMOGLOBIN CALIBRATORS | Miles Laboratories, Inc. | 1982-07-30 |
| K800852 | HEMESPEC CHECK SET | Helena Laboratories | 1980-05-02 |
| K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD | Sandare Chemical Co., Inc. | 1979-12-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414287201 | Atellica HEMA Calibrator | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00380740151294 | Alinity | Abbott GmbH | 2023-11-16 |
| 00630414600826 | ADVIA® 360/560 Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414224343 | ADVIA® 120/2120/2120i SETpoint | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630921096 | Cfas HbA1c | Roche Diagnostics GmbH | 2016-09-20 |
| 30844509000311 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 30844509000243 | Cal-Chex | STRECK, INC. | 2016-09-16 |
| 20844509000246 | Cal-Chex | STRECK, INC. | 2016-09-16 |
| 40844509000318 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 20844509000314 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 00847817013966 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817014154 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817014406 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817000324 | VARIANT II Hemoglobin A1c | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817011979 | VARIANT II Hemoglobin A1c | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817014871 | VARIANT II TURBO Link | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00380740003623 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003616 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003609 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00812137010223 | Boule Cal | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | 2016-09-06 |
| 00812137010360 | CDS Hematology Calibrator | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | 2016-09-02 |
| 00812137010421 | CDS Hematology Calibrator | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | 2016-09-02 |
| 00380740017071 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740020347 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |