JPI — Device, Hematocrit Measuring Class II
FDA product code JPI covers "Device, Hematocrit Measuring", a Class II medical device regulated under 21 CFR 864.6400. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JPI
- Device Class
- Class II
- Regulation Number
- 864.6400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183680 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 28, 2020 |
| K163342 | abbott laboratories | i-STAT Hematocrit test with i-STAT Alinity System | August 22, 2017 |
| K950942 | in-line diagnostics | CRIT-LINE HEMATOCRIT ALERT | March 14, 1995 |
| K924167 | noninvasive medical technology | CRIT-LINE | May 7, 1993 |
| K903698 | statspin technologies | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | September 17, 1990 |
| K902028 | norfolk scientific | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | June 20, 1990 |
| K870511 | norfolk scientific | CHART-TYPE MICRO HEMATOCRIT TUBE READER | March 16, 1987 |
| K852516 | whittaker general medical | CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE | July 15, 1985 |
| K852482 | em diagnostic systems | MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 | July 15, 1985 |
| K850391 | hans j. brouwers and assoc | PLASMA EXTRACTION SYSTEM | May 10, 1985 |
| K840767 | heraeus-christ | HAEMOFUGE A. BIOFUGE A. & B | April 17, 1984 |
| K831318 | worthington diagnostic systems | COMPUR* M1100 HEMATRCRIT SYSTEM | June 8, 1983 |
| K830578 | fisher scientific co | MICROHEMATOCRIT READER | March 24, 1983 |
| K823558 | fisher scientific co | MICRO-HEMATOCRIT CENTRIFUGE 335/336 | January 21, 1983 |
| K822716 | biodynamics | UNIVERSAL CENTRIFUGE | September 30, 1982 |