KRX · Calibrator For Cell Indices
Hematology · 21 CFR 864.8150 · Class 2
Overview
| Product Code | KRX |
|---|---|
| Device Name | Calibrator For Cell Indices |
| Regulation | 21 CFR 864.8150 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160585 | XN CAL | Streck | Dec 22, 2016 | SESE |
| K141962 | XN CAL | Streck | Dec 5, 2014 | SESE |
| K141955 | XN CAL PF | Streck | Dec 5, 2014 | SESE |
| K120747 | XN CAL PF | Streck | Oct 22, 2012 | SESE |
| K120745 | XN CAL | Streck | Oct 19, 2012 | SESE |
| K111204 | CELL-DYN 22 PLUS CALIBRATOR | Streck | Dec 22, 2011 | SESE |
| K083200 | X-CAL | Streck | Feb 3, 2009 | SESE |
| K020469 | CAL-CHEX CD PLUS | Streck Laboratories, Inc. | Apr 4, 2002 | SESE |
| K003991 | CD-CAL PLUS CALIBRATOR | R&D Systems, Inc. | Jan 16, 2001 | SESE |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Clinical Diagnostic Solutions, Inc. | Dec 20, 1999 | SESE |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | R&D Systems, Inc. | Feb 29, 1996 | SESE |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | Jul 9, 1991 | SESE |
| K862858 | CBC-CAL (TM) PLUS/MULTIPLE | R&D Systems, Inc. | Aug 21, 1986 | SESE |
| K831140 | DADE HEMATOLOGY CALIBRATOR | American Dade | Jun 8, 1983 | SESE |
| K811741 | CELL-CHEX RBC | Streck Laboratories, Inc. | Sep 24, 1981 | SESE |
| K811063 | LASER-CAL | Diagnostic Technology, Inc. | Jul 1, 1981 | SESE |
Top Applicants
- Streck — 7 clearances
- R&D Systems, Inc. — 4 clearances
- Streck Laboratories, Inc. — 2 clearances
- American Dade — 1 clearance
- Clinical Diagnostic Solutions, Inc. — 1 clearance
