i-STAT Hematocrit test with i-STAT Alinity System
FDA 510(k) K163342 · Abbott Laboratories
510(k) numberK163342
Submission
- Device name
- i-STAT Hematocrit test with i-STAT Alinity System
- Applicant
- Abbott Laboratories
Princton, NJ, US - Received
- November 29, 2016
- Decision date
- August 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPI – Device, Hematocrit Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6400
- Specialty
- Hematology
Other 510(k)s with product code JPI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJPI · Traditional | Abbott Point of Care, Inc. | 02/28/2020SE |
| K950942 | Crit-Line Hematocrit AlertJPI · Traditional | In-Line Diagnostics Corp. | 03/14/1995SE |
| K924167 | Crit-LineJPI · Traditional | Noninvasive Medical Technology Corp. | 05/07/1993SE |
| K903698 | Statspin Micro-Hematocrit Reader for 75MM TubesJPI · Traditional | Statspin Technologies | 09/17/1990SE |
| K902028 | Statspin Illuminated Micro-Hematocrit Tube ReaderJPI · Traditional | Norfolk Scientific, Inc. | 06/20/1990SE |
| K870511 | Chart-Type Micro Hematocrit Tube ReaderJPI · Traditional | Norfolk Scientific, Inc. | 03/16/1987SE |
| K852516 | Centifuge, Hematocrit & Microsedimentation CombineJPI · Traditional | Whittaker General Medical | 07/15/1985SE |
| K852482 | Microspin Minicentrifuge Item No. 65204/94JPI · Traditional | Em Diagnostic Systems, Inc. | 07/15/1985SE |
| K850391 | Plasma Extraction SystemJPI · Traditional | Hans J. Brouwers & Assoc. | 05/10/1985SE |
| K840767 | Haemofuge A. Biofuge A. & BJPI · Traditional | Heraeus-Christ GmbH | 04/17/1984SE |
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Questions and answers
When was i-STAT Hematocrit test with i-STAT Alinity System cleared by the FDA?
i-STAT Hematocrit test with i-STAT Alinity System (K163342) received a 510(k) decision of Substantially Equivalent on August 22, 2017, 266 days after the submission was received.
What is the product code of K163342?
The FDA product code is JPI – Device, Hematocrit Measuring, a Class II (moderate risk) device regulated under 21 CFR 864.6400.