Panels › Hematology › Product code KQI · Class 2
Assay, Fetal Hemoglobin
Regulation 864.7455
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 3 | 0 |
| Isolab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 1988 | K880653 | HBF DILUENT Helena Laboratories | KQI |
| Sep 1, 1981 | K812226 | HELENA HBF QUIPLATE CONTROL Helena Laboratories | KQI |
| Mar 26, 1981 | K810475 | HELENA HEMOGLOBIN F CONTROLS Helena Laboratories | KQI |
| Jul 17, 1979 | K791143 | SICKLE-CELL F TEST Isolab, Inc. | KQI |
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