FDA Product Code
FDA Product Code JPI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6400
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-28 | Traditional | PDF ↗ |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | 2017-08-22 | Traditional | PDF ↗ |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | In-Line Diagnostics Corp. | 1995-03-14 | Traditional | PDF ↗ |
| K924167 | CRIT-LINE | Noninvasive Medical Technology Corp. | 1993-05-07 | Traditional | PDF ↗ |
| K903698 | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | Statspin Technologies | 1990-09-17 | Traditional | PDF ↗ |
| K902028 | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K870511 | CHART-TYPE MICRO HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K852482 | MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 | Em Diagnostic Systems, Inc. | 1985-07-15 | Traditional | PDF ↗ |
| K852516 | CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE | Whittaker General Medical | 1985-07-15 | Traditional | PDF ↗ |
| K850391 | PLASMA EXTRACTION SYSTEM | Hans J. Brouwers & Assoc. | 1985-05-10 | Traditional | PDF ↗ |
| K840767 | HAEMOFUGE A. BIOFUGE A. & B | Heraeus-Christ GmbH | 1984-04-17 | Traditional | PDF ↗ |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Worthington Diagnostic Systems | 1983-06-08 | Traditional | PDF ↗ |
| K830578 | MICROHEMATOCRIT READER | Fisher Scientific Co., LLC | 1983-03-24 | Traditional | PDF ↗ |
| K823558 | MICRO-HEMATOCRIT CENTRIFUGE 335/336 | Fisher Scientific Co., LLC | 1983-01-21 | Traditional | PDF ↗ |
| K822716 | UNIVERSAL CENTRIFUGE | Biodynamics Corp. | 1982-09-30 | Traditional | PDF ↗ |
Product code JPI · Class II · Hematology. Data: openFDA.