Coagulation Control Plasma Level 1/2/3
FDA 510(k) K841461 · Diatech, Inc.
510(k) numberK841461
Submission
- Device name
- Coagulation Control Plasma Level 1/2/3
- Applicant
- Diatech, Inc.
Mchenry, IL, US - Received
- April 9, 1984
- Decision date
- May 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K881685 | Fibrinogentest-OGIS · Traditional | 08/09/1988SE |
| K854938 | Coascreener/Diascreenerblood Plasma Timing Inst.JPA · Traditional | 03/12/1986SE |
| K854090 | DIATIMER-2 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K854089 | DIATIMER-1 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K842286 | Dia T1, T2 & T3JPK · Traditional | 09/11/1984SE |
| K841523 | Owren's Veronal BufferrJPA · Traditional | 06/01/1984SE |
| K841462 | Heparin Coagulation Control Plasma 1-JPA · Traditional | 06/01/1984SE |
| K841366 | Dia FibrinKQJ · Traditional | 06/01/1984SE |
| K841365 | Dia ReptinGIR · Traditional | 06/01/1984SE |
| K840802 | Dia Thrombin Dia PlastinGJS · Traditional | 05/01/1984SE |
Questions and answers
When was Coagulation Control Plasma Level 1/2/3 cleared by the FDA?
Coagulation Control Plasma Level 1/2/3 (K841461) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 23 days after the submission was received.
What is the product code of K841461?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.