Coagulation Control, Level II
FDA 510(k) K870686 · U. S. Diagnostics, Inc.
510(k) numberK870686
Submission
- Device name
- Coagulation Control, Level II
- Applicant
- U. S. Diagnostics, Inc.
San Luis Obispo, CA, US - Received
- February 19, 1987
- Decision date
- April 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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|---|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | Diagnostica Stago, Inc. | 04/27/2026SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | Sysmex America, Inc. | 06/02/2025SE |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics Corporation | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
| K233790 | Acl Top 970 CLJPA · Special | Instrumentation Laboratory | 12/29/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | Instrumentation Laboratory CO | 09/29/2023SE |
| K212183 | STA R Max 3, STA Compact Max 3JPA · Traditional | Diagnostica Stago S.A.S | 06/07/2023SE |
| K201440 | ROTEM sigma Thromboelastometry SystemJPA · Traditional | Tem Innovations GmbH | 07/08/2022SE |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional | Accriva Diagnostics, Inc. | 12/29/2021SE |
More from Accriva Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K110435 | Easygluco Plus Blood Glucose Monitoring SystemNBW · Special | 09/21/2011SE |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024ANBW · Traditional | 02/20/2009SE |
| K061431 | Easygluco, Model IGM-0002 G2CGA · Traditional | 01/12/2007SE |
| K051651 | G4, Model IGM-0004NBW · Traditional | 04/14/2006SE |
| K870687 | Coagulation Control, Level IIIJPA · Traditional | 04/20/1987SE |
| K870685 | Coagulation Control, Level IJPA · Traditional | 04/20/1987SE |
| K870596 | Prothrombin Time TestGJS · Traditional | 04/20/1987SE |
| K871283 | Cyanmethemoglobin StandardKRZ · Traditional | 04/15/1987SE |
| K870738 | U.S. Diagnostics Liquid CK Isoenzyme ControlJJT · Traditional | 04/13/1987SE |
| K870737 | U.S. Diagnostics Liquid LD Isoenzyme ControlJJT · Traditional | 04/13/1987SE |
Questions and answers
When was Coagulation Control, Level II cleared by the FDA?
Coagulation Control, Level II (K870686) received a 510(k) decision of Substantially Equivalent on April 20, 1987, 60 days after the submission was received.
What is the product code of K870686?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.