Product code JPI
- Device name
- Device, Hematocrit Measuring
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.6400
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-28 |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | 2017-08-22 |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | In-Line Diagnostics Corp. | 1995-03-14 |
| K924167 | CRIT-LINE | Noninvasive Medical Technology Corp. | 1993-05-07 |
| K903698 | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | Statspin Technologies | 1990-09-17 |
| K902028 | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | 1990-06-20 |
| K870511 | CHART-TYPE MICRO HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | 1987-03-16 |
| K852482 | MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 | Em Diagnostic Systems, Inc. | 1985-07-15 |
| K852516 | CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE | Whittaker General Medical | 1985-07-15 |
| K850391 | PLASMA EXTRACTION SYSTEM | Hans J. Brouwers & Assoc. | 1985-05-10 |
| K840767 | HAEMOFUGE A. BIOFUGE A. & B | Heraeus-Christ GmbH | 1984-04-17 |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Worthington Diagnostic Systems | 1983-06-08 |
| K830578 | MICROHEMATOCRIT READER | Fisher Scientific Co., LLC | 1983-03-24 |
| K823558 | MICRO-HEMATOCRIT CENTRIFUGE 335/336 | Fisher Scientific Co., LLC | 1983-01-21 |
| K822716 | UNIVERSAL CENTRIFUGE | Biodynamics Corp. | 1982-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 00385480167291 | NOVA | NOVA BIOMEDICAL CORPORATION | 2017-04-24 |
| 00385480118026 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-22 |
| 00385480141567 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480167284 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480152150 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480150866 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480148443 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480148306 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480145756 | Nova | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480142441 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480139847 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480132039 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480128827 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480132114 | Nova | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480131964 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131957 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131438 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131421 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480115339 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170925 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170932 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175142 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175180 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 10054749000163 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |