STA R Max 3, STA Compact Max 3
FDA 510(k) K212183 · Diagnostica Stago S.A.S
510(k) numberK212183
Submission
- Device name
- STA R Max 3, STA Compact Max 3
- Applicant
- Diagnostica Stago S.A.S
Asniéres Sur Seine, FR - Received
- July 13, 2021
- Decision date
- June 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code JPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K193041 | Hemochron Signature EliteJPA · Special | Accriva Diagnostics, Inc. | 11/22/2019SE |
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Questions and answers
When was STA R Max 3, STA Compact Max 3 cleared by the FDA?
STA R Max 3, STA Compact Max 3 (K212183) received a 510(k) decision of Substantially Equivalent on June 7, 2023, 694 days after the submission was received.
What is the product code of K212183?
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.