FDA Product Code
FDA Product Code KRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8150
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160585 | XN CAL | Streck | 2016-12-22 | Traditional | PDF ↗ |
| K141955 | XN CAL PF | Streck | 2014-12-05 | Traditional | PDF ↗ |
| K141962 | XN CAL | Streck | 2014-12-05 | Traditional | PDF ↗ |
| K120747 | XN CAL PF | Streck | 2012-10-22 | Traditional | PDF ↗ |
| K120745 | XN CAL | Streck | 2012-10-19 | Traditional | PDF ↗ |
| K111204 | CELL-DYN 22 PLUS CALIBRATOR | Streck | 2011-12-22 | Traditional | PDF ↗ |
| K083200 | X-CAL | Streck | 2009-02-03 | Traditional | PDF ↗ |
| K020469 | CAL-CHEX CD PLUS | Streck Laboratories, Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K003991 | CD-CAL PLUS CALIBRATOR | R&D Systems, Inc. | 2001-01-16 | Special | PDF ↗ |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Clinical Diagnostic Solutions, Inc. | 1999-12-20 | Abbreviated | PDF ↗ |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | R&D Systems, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1991-07-09 | Traditional | PDF ↗ |
| K862858 | CBC-CAL (TM) PLUS/MULTIPLE | R&D Systems, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K831140 | DADE HEMATOLOGY CALIBRATOR | American Dade | 1983-06-08 | Traditional | PDF ↗ |
| K811741 | CELL-CHEX RBC | Streck Laboratories, Inc. | 1981-09-24 | Traditional | PDF ↗ |
| K811063 | LASER-CAL | Diagnostic Technology, Inc. | 1981-07-01 | Traditional | PDF ↗ |
Product code KRX · Class II · Hematology. Data: openFDA.