FDA product code KRY: Calibrator For Platelet Counting
KRY is the FDA product code for calibrator for platelet counting. It is a Class II device, regulated under 21 CFR 864.8175 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under KRY, from 5 different applicants. The average 510(k) review took 132 days (median 66). FDA has posted 1 recall for KRY devices.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator For Platelet Counting |
| Device class | Class II |
| Regulation | 21 CFR 864.8175 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KRY clearance
Top KRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coulter Electronics, Inc. | 3 | 1987-05-20 |
| Streck Laboratories, Inc. | 2 | 1978-10-10 |
| R&D Systems, Inc. | 1 | 1985-07-09 |
| Immunogenetics | 1 | 1982-09-02 |
| Technicon Instruments Corp. | 1 | 1978-01-30 |
Most recent KRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862122 | Coulter Electronics, Inc. | S-CAL HEMATOLOGY CALIBRATOR | 1987-05-20 | 351 |
| K852016 | R&D Systems, Inc. | LASER PLATELETCAL/MULTIPLE | 1985-07-09 | 61 |
| K843910 | Coulter Electronics, Inc. | COULTER MEAN PLATELET VOLUME CALIBRATOR | 1985-01-07 | 96 |
| K840794 | Coulter Electronics, Inc. | S-CAL HEMATOLOGY CALIBRATOR | 1984-04-04 | 41 |
| K821851 | Immunogenetics | CONTROL DIAGNOSTICS PLATELET CONTROL | 1982-09-02 | 71 |
Recalls for KRY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-09-18.
Frequently asked questions
What is FDA product code KRY?
KRY is the FDA product code for calibrator for platelet counting. It is a Class II device, regulated under 21 CFR 864.8175 and reviewed by the Hematology panel.
What device class is KRY?
Class II, regulation 21 CFR 864.8175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KRY?
Across 8 cleared submissions the average was 132 days from receipt to decision (median 66).
Which companies have the most KRY clearances?
Coulter Electronics, Inc. (3); Streck Laboratories, Inc. (2); R&D Systems, Inc. (1); Immunogenetics (1); Technicon Instruments Corp. (1).
Have KRY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-09-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KRY
- Run a recall and safety report across every KRY manufacturer
- Watch product code KRY 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.
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