Product code JPI— Hematology
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
- Classification name
- Device, Hematocrit Measuring
- Device class
- Class 2
- Regulation
- 21 CFR 864.6400
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code JPI
FDA has cleared devices under product code JPI between 1982 and 2020, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2017
- 1995
- 1993
- 1990
- 1987
- 1985
- 1984
- 1983
- 1982
Top applicants under product code JPI
Recent clearances under product code JPI
- K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K163342 — i-STAT Hematocrit test with i-STAT Alinity System
- K950942 — CRIT-LINE HEMATOCRIT ALERT
- K924167 — CRIT-LINE
- K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
- K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
- K870511 — CHART-TYPE MICRO HEMATOCRIT TUBE READER
- K852482 — MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
- K852516 — CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
- K850391 — PLASMA EXTRACTION SYSTEM
- K840767 — HAEMOFUGE A. BIOFUGE A. & B
- K831318 — COMPUR* M1100 HEMATRCRIT SYSTEM
- K830578 — MICROHEMATOCRIT READER
- K823558 — MICRO-HEMATOCRIT CENTRIFUGE 335/336
- K822716 — UNIVERSAL CENTRIFUGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.