Product code KRX
- Device name
- Calibrator For Cell Indices
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8150
- 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 |
|---|---|---|---|
| K160585 | XN CAL | Streck | 2016-12-22 |
| K141955 | XN CAL PF | Streck | 2014-12-05 |
| K141962 | XN CAL | Streck | 2014-12-05 |
| K120747 | XN CAL PF | Streck | 2012-10-22 |
| K120745 | XN CAL | Streck | 2012-10-19 |
| K111204 | CELL-DYN 22 PLUS CALIBRATOR | Streck | 2011-12-22 |
| K083200 | X-CAL | Streck | 2009-02-03 |
| K020469 | CAL-CHEX CD PLUS | Streck Laboratories, Inc. | 2002-04-04 |
| K003991 | CD-CAL PLUS CALIBRATOR | R&D Systems, Inc. | 2001-01-16 |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Clinical Diagnostic Solutions, Inc. | 1999-12-20 |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | R&D Systems, Inc. | 1996-02-29 |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1991-07-09 |
| K862858 | CBC-CAL (TM) PLUS/MULTIPLE | R&D Systems, Inc. | 1986-08-21 |
| K831140 | DADE HEMATOLOGY CALIBRATOR | American Dade | 1983-06-08 |
| K811741 | CELL-CHEX RBC | Streck Laboratories, Inc. | 1981-09-24 |
| K811063 | LASER-CAL | Diagnostic Technology, Inc. | 1981-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00815762023453 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2025-12-01 |
| 00815762023446 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2025-12-01 |
| 06936415992927 | SC-CAL PLUS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-01-17 |
| 00380740151294 | Alinity | Abbott GmbH | 2023-11-16 |
| 14987562460592 | X-CAL Calibrator | SYSMEX CORPORATION | 2017-10-06 |
| 14987562460356 | XN CAL PF | SYSMEX CORPORATION | 2017-10-06 |
| 14987562460332 | XN CAL | SYSMEX CORPORATION | 2017-10-06 |
| D757U2260K1 | One Step Plus KIT | BISCO INC. | 2017-06-12 |
| 06944904084152 | SC-CAL PLUS Calibrator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-23 |
| 15099590639426 | COULTER AcT | Beckman Coulter, Inc. | 2016-09-23 |
| 30844509000311 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 20844509000314 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 40844509000318 | Cal-Chex A Plus | STRECK, INC. | 2016-09-16 |
| 00817274020258 | Drew Scientific | DREW SCIENTIFIC, INC. | 2016-09-09 |
| 00812137010254 | CDS-LTX CONTROL | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | 2016-09-08 |
| 00856605006004 | MINOCAL | HORIBA INSTRUMENTS INCORPORATED | 2016-08-10 |
| 00856605006103 | MINOCAL | HORIBA INSTRUMENTS INCORPORATED | 2016-08-10 |
| 14987562460349 | XN CAL PF | SYSMEX CORPORATION | 2016-08-04 |
| 14987562460585 | X-CAL Calibrator | SYSMEX CORPORATION | 2016-08-04 |
| 14987562460325 | XN CAL | SYSMEX CORPORATION | 2016-08-04 |
| 10815762020473 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 20815762020470 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 20815762020937 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 30815762020477 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021166 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020930 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 00815762020483 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020541 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020503 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 00380740017071 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |