Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
FDA 510(k) clearance K223635 · decided 2023-01-04
Clearance details
- K-number
- K223635
- Device name
- Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
- Applicant
- Sienco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-05
- Decision date
- 2023-01-04
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RAPIDTEG TEG-ACT TEST (K062604) | Haemoscope Corp. | 2007-01-31 |
| AIACT KIT (K032952) | Sienco, Inc. | 2003-12-12 |
| I-STAT KAOLIN ACT TEST (K023582) | I-Stat Corporation | 2003-09-08 |
| ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (K020914) | Helena Laboratories | 2002-05-23 |
| ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (K013078) | Helena Laboratories | 2002-01-10 |
| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528) | Sienco, Inc. | 2000-08-31 |
| (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (K994194) | Cardiovascular Diagnostics, Inc. | 2000-03-28 |
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |
| ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851) | Roche Diagnostics Corp. | 2000-01-14 |
| GBACT + KIT (K984141) | Sienco, Inc. | 1999-05-28 |
| MAX-ACT (K983649) | Array Medical, Inc. | 1998-12-11 |
| B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) (K971935) | B & D Corp. | 1997-10-01 |
Recalls involving this device
No recalls on record reference this clearance.