KRX
16 FDA 510(k) clearances · Product code
96 daysmedian time to decision
237 days90th percentile
16clearances measured
FDA profile
- Official device name
- Calibrator For Cell Indices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8150
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| XN CAL (K160585) | Streck | 2016-12-22 |
| XN CAL (K141962) | Streck | 2014-12-05 |
| XN CAL PF (K141955) | Streck | 2014-12-05 |
| XN CAL PF (K120747) | Streck | 2012-10-22 |
| XN CAL (K120745) | Streck | 2012-10-19 |
| CELL-DYN 22 PLUS CALIBRATOR (K111204) | Streck | 2011-12-22 |
| X-CAL (K083200) | Streck | 2009-02-03 |
| CAL-CHEX CD PLUS (K020469) | Streck Laboratories, Inc. | 2002-04-04 |
| CD-CAL PLUS CALIBRATOR (K003991) | R&D Systems, Inc. | 2001-01-16 |
| CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (K993375) | Clinical Diagnostic Solutions, Inc. | 1999-12-20 |
| CBC-CAL PLUS HEMATOLOGY CALIBRATOR (K955925) | R&D Systems, Inc. | 1996-02-29 |
| 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE (K912357) | R&D Systems, Inc. | 1991-07-09 |
| CBC-CAL (TM) PLUS/MULTIPLE (K862858) | R&D Systems, Inc. | 1986-08-21 |
| DADE HEMATOLOGY CALIBRATOR (K831140) | American Dade | 1983-06-08 |
| CELL-CHEX RBC (K811741) | Streck Laboratories, Inc. | 1981-09-24 |
| LASER-CAL (K811063) | Diagnostic Technology, Inc. | 1981-07-01 |
Track KRX automatically
Every clearance here is in the API, with alerts when new ones post.