510(k) K163342
- Device
- I-STAT Hematocrit Test With I-STAT Alinity System
- Applicant
- Abbott Laboratories
- 510(k) number
- K163342
- Product code
- JPI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-22
- Date received
- 2016-11-29
- Regulation
- 864.6400
- Classification name
- Device, Hematocrit Measuring
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tamara McCaw
- Address
- 400 College Rd. E. Princton NJ US 08540 08540
FDA Registration Numbers#
- 3005643513
- 3014506106
- 3005990076
- 3023162659
- 3012817228
- 2245578
- 2050012
- 3013513377
- 3006198300
- 1219029
- 3004959793
- 1061932
- 1925253
Source Documents#
Other 510(k) Records For Product Code JPI #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary