Panels › Hematology › Product code GKA · Class 2
Abnormal Hemoglobin Quantitation
Regulation 864.7415
0510(k)s in 12 months (23 all time)
0recalls in 12 months (10 all time)
4recalls that name a 510(k)
Top companies in GKA
| Company | 510(k)s | Recalls |
|---|---|---|
| Sebia | 7 | 0 |
| Bio-Rad Laboratories, Inc. | 2 | 3 |
| Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 0 | 5 |
| Bio-Rad | 3 | 0 |
| Helena Laboratories | 3 | 0 |
| Primus Corp. | 1 | 1 |
| Beckman Instruments, Inc. | 1 | 0 |
| Bio-Rad Laboratories Inc., Clinical Systems Divisi | 1 | 0 |
| Interlab S.R.L. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2022 | Bio-Rad Laboratories, Inc. Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 Open, Classified |
GKA | K051072 |
| Oct 9, 2020 | Primus Corporation Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation Terminated |
GKA | K955283 |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use on Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic Terminated |
GKA | None listed |
| Apr 14, 2011 | Bio-Rad Laboratories Inc VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intende Terminated |
GKA | None listed |
| Mar 29, 2011 | Bio-Rad Laboratories Inc The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The VARIANT Sickle Cell Short Program is designed as a qualitative screen f Terminated |
GKA | K924813 |
| Oct 28, 2004 | PerkinElmer LAS Inc RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 360 Terminated |
GKA | K840011 |
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