Panels › Hematology › Product code GKR · Class 2
System, Hemoglobin, Automated
Regulation 864.5620
0510(k)s in 12 months (39 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in GKR
| Company | 510(k)s | Recalls |
|---|---|---|
| Hemocue AB | 6 | 1 |
| Ekf Diagnostic GmbH | 4 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 4 |
| Stanbio Laboratory | 3 | 1 |
| Helena Laboratories | 2 | 0 |
| Hematology Marketing Assoc. | 2 | 0 |
| Immunostics Inc., | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Aktiebolaget Leo Diagnostics | 1 | 0 |
| Avl Scientific Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395
Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, Terminated |
GKR | K031560 |
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393
Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, Terminated |
GKR | K031560 |
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306
Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, elec Terminated |
GKR | K020616 |
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055,
10321238, 10322347, 10328278, 10328302, 10336784
Device is point-of-care system for comprehensive lab-q Terminated |
GKR | K020616 |
| Feb 8, 2018 | Stanbio Laboratory, LP Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. Terminated |
GKR | K081719 |
| Oct 29, 2013 | HemoCue AB HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden Terminated |
GKR | K032203 |
| Mar 31, 2011 | ITC-Nexus Dx, Inc. HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corpo Terminated |
GKR | None listed |
| Mar 30, 2011 | Hemo Cue, Inc. HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Terminated |
GKR | K041234 |
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