Calibrator For Cell Indices
This device is a calibrator used to standardize hematology analyzers for the measurement of red cell indices such as mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration, ensuring accurate and reproducible test results. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRX, regulated under 21 CFR 864.8150 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KRX
- Device Class
- FDA class 2
- Regulation Number
- 864.8150
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160585 | XN CAL | Dec 22, 2016 | Substantially Equivalent | Streck |
| K141962 | XN CAL | Dec 05, 2014 | Substantially Equivalent | Streck |
| K141955 | XN CAL PF | Dec 05, 2014 | Substantially Equivalent | Streck |
| K120747 | XN CAL PF | Oct 22, 2012 | Substantially Equivalent | Streck |
| K120745 | XN CAL | Oct 19, 2012 | Substantially Equivalent | Streck |
| K111204 | CELL-DYN 22 PLUS CALIBRATOR | Dec 22, 2011 | Substantially Equivalent | Streck |
| K083200 | X-CAL | Feb 03, 2009 | Substantially Equivalent | Streck |
| K020469 | CAL-CHEX CD PLUS | Apr 04, 2002 | Substantially Equivalent | Streck Laboratories, Inc. |
| K003991 | CD-CAL PLUS CALIBRATOR | Jan 16, 2001 | Substantially Equivalent | R&D Systems, Inc. |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Dec 20, 1999 | Substantially Equivalent | Clinical Diagnostic Solutions, Inc. |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | Feb 29, 1996 | Substantially Equivalent | R&D Systems, Inc. |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | Jul 09, 1991 | Substantially Equivalent | R&D Systems, Inc. |
| K862858 | CBC-CAL (TM) PLUS/MULTIPLE | Aug 21, 1986 | Substantially Equivalent | R&D Systems, Inc. |
| K831140 | DADE HEMATOLOGY CALIBRATOR | Jun 08, 1983 | Substantially Equivalent | American Dade |
| K811741 | CELL-CHEX RBC | Sep 24, 1981 | Substantially Equivalent | Streck Laboratories, Inc. |
| K811063 | LASER-CAL | Jul 01, 1981 | Substantially Equivalent | Diagnostic Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.