Coag-I Analyzer, Alpha Model
FDA 510(k) K882444 · Cardiovascular Diagnostic Services
510(k) numberK882444
Submission
- Device name
- Coag-I Analyzer, Alpha Model
- Applicant
- Cardiovascular Diagnostic Services
Research Triangle Park, NC, US - Received
- June 14, 1988
- Decision date
- August 25, 1988
- 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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| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics | 04/30/2025SE |
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| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
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| 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 |
|---|---|---|
| K955843 | Tas PtoneGJS · Traditional | 03/18/1996SE |
| K933092 | Tas AnalyzerGKP · Traditional | 11/15/1993SE |
| K904325 | COAG-1 Pt-Nc Test CardGJS · Traditional | 01/25/1991SE |
| K903019 | Modified COAG-1 PT Test CardGJS · Traditional | 08/01/1990SE |
| K891015 | COAG-1 Aptt Test CardGFO · Traditional | 05/22/1989SE |
| K882456 | Coag-I PT Test CardGJS · Traditional | 08/25/1988SE |
| K812304 | Dorros-Spring PressurizerMAV · Traditional | 10/13/1981SE |
Questions and answers
When was Coag-I Analyzer, Alpha Model cleared by the FDA?
Coag-I Analyzer, Alpha Model (K882444) received a 510(k) decision of Substantially Equivalent on August 25, 1988, 72 days after the submission was received.
What is the product code of K882444?
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.