FDA product code KRX: Calibrator For Cell Indices
KRX is the FDA product code for calibrator for cell indices. It is a Class II device, regulated under 21 CFR 864.8150 and reviewed by the Hematology panel. FDA has cleared 16 510(k) submissions under KRX, from 6 different applicants. The average 510(k) review took 117 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator For Cell Indices |
| Device class | Class II |
| Regulation | 21 CFR 864.8150 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KRX clearance
Top KRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck | 7 | 2016-12-22 |
| R&D Systems, Inc. | 4 | 2001-01-16 |
| Streck Laboratories, Inc. | 2 | 2002-04-04 |
| Clinical Diagnostic Solutions, Inc. | 1 | 1999-12-20 |
| American Dade | 1 | 1983-06-08 |
1 more applicants have KRX clearances. See the full list in Caduvo.
Most recent KRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160585 | Streck | XN CAL | 2016-12-22 | 296 |
| K141955 | Streck | XN CAL PF | 2014-12-05 | 140 |
| K141962 | Streck | XN CAL | 2014-12-05 | 140 |
| K120747 | Streck | XN CAL PF | 2012-10-22 | 224 |
| K120745 | Streck | XN CAL | 2012-10-19 | 221 |
Recalls for KRX devices
openFDA lists no recalls for product code KRX.
Frequently asked questions
What is FDA product code KRX?
KRX is the FDA product code for calibrator for cell indices. It is a Class II device, regulated under 21 CFR 864.8150 and reviewed by the Hematology panel.
What device class is KRX?
Class II, regulation 21 CFR 864.8150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KRX?
Across 16 cleared submissions the average was 117 days from receipt to decision (median 86).
Which companies have the most KRX clearances?
Streck (7); R&D Systems, Inc. (4); Streck Laboratories, Inc. (2); Clinical Diagnostic Solutions, Inc. (1); American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KRX
- Run a recall and safety report across every KRX manufacturer
- Watch product code KRX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times