Panels › Hematology › Product code KRY · Class 2
Calibrator For Platelet Counting
Regulation 864.8175
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KRY
| Company | 510(k)s | Recalls |
|---|---|---|
| Coulter Electronics, Inc. | 3 | 0 |
| Streck Laboratories, Inc. | 2 | 0 |
| Abbott Laboratories | 0 | 1 |
| Immunogenetics | 1 | 0 |
| R&D Systems, Inc. | 1 | 0 |
| Technicon Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 1987 | K862122 | S-CAL HEMATOLOGY CALIBRATOR Coulter Electronics, Inc. | KRY |
| Jul 9, 1985 | K852016 | LASER PLATELETCAL/MULTIPLE R&D Systems, Inc. | KRY |
| Jan 7, 1985 | K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR Coulter Electronics, Inc. | KRY |
| Apr 4, 1984 | K840794 | S-CAL HEMATOLOGY CALIBRATOR Coulter Electronics, Inc. | KRY |
| Sep 2, 1982 | K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL Immunogenetics | KRY |
| Oct 10, 1978 | K781601 | TEKNI-CAL Streck Laboratories, Inc. | KRY |
| Aug 14, 1978 | K781133 | PC-CALIBRATOR Streck Laboratories, Inc. | KRY |
| Jan 30, 1978 | K770143 | TQC CALIBRATION REFERENCE FOR PLATELETS Technicon Instruments Corp. | KRY |
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