i-STAT Hematocrit test with i-STAT Alinity System
FDA 510(k) clearance K163342 · decided 2017-08-22
Clearance details
- K-number
- K163342
- Device name
- i-STAT Hematocrit test with i-STAT Alinity System
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2016-11-29
- Decision date
- 2017-08-22
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- JPI
- Device class
- 2
- Regulation number
- 864.6400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Princton, NJ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183680) | Abbott Point of Care, Inc. | 2020-02-28 |
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| CRIT-LINE (K924167) | Noninvasive Medical Technology Corp. | 1993-05-07 |
| STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (K903698) | Statspin Technologies | 1990-09-17 |
| STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (K902028) | Norfolk Scientific, Inc. | 1990-06-20 |
| CHART-TYPE MICRO HEMATOCRIT TUBE READER (K870511) | Norfolk Scientific, Inc. | 1987-03-16 |
| MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (K852482) | Em Diagnostic Systems, Inc. | 1985-07-15 |
| CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (K852516) | Whittaker General Medical | 1985-07-15 |
| PLASMA EXTRACTION SYSTEM (K850391) | Hans J. Brouwers & Assoc. | 1985-05-10 |
| HAEMOFUGE A. BIOFUGE A. & B (K840767) | Heraeus-Christ GmbH | 1984-04-17 |
| COMPUR* M1100 HEMATRCRIT SYSTEM (K831318) | Worthington Diagnostic Systems | 1983-06-08 |
| MICROHEMATOCRIT READER (K830578) | Fisher Scientific Co., LLC | 1983-03-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |