Panels › Hematology › Product code JPI · Class 2
Device, Hematocrit Measuring
Regulation 864.6400
0510(k)s in 12 months (15 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in JPI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Point of Care, Inc. | 1 | 8 |
| Fisher Scientific Co., LLC | 2 | 0 |
| Norfolk Scientific, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Baxter Healthcare Renal Div | 0 | 1 |
| Biodynamics Corp. | 1 | 0 |
| Em Diagnostic Systems, Inc. | 1 | 0 |
| Hans J. Brouwers & Assoc. | 1 | 0 |
| Heraeus-Christ GmbH | 1 | 0 |
| In-Line Diagnostics Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT E3+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key Terminated |
JPI | K912387 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EC4+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | K912387 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT 6+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key Terminated |
JPI | K912387 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EC8+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | K040919 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EG6+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | K940918 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EG7+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | K940918 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT CG8+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | K040918 |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT CHEM8+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a Terminated |
JPI | K053110 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
JPI | K970446 |
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