Fibrinogentest-O
FDA 510(k) K881685 · Diatech, Inc.
510(k) numberK881685
Submission
- Device name
- Fibrinogentest-O
- Applicant
- Diatech, Inc.
Fort Lauderdale, FL, US - Received
- April 19, 1988
- Decision date
- August 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIS – Test, Fibrinogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
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| K993482 | K-Assay FibrinogenGIS · Traditional | Kamiya Biomedical Co. | 12/06/1999SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | Ortho Diagnostic Systems, Inc. | 11/29/1996SE |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | Diagnostic Specialties | 08/30/1994SE |
| K925494 | Biomerieux Hemolab FibrinomatGIS · Traditional | Biomerieux Vitek, Inc. | 05/18/1993SE |
| K923921 | Il Test PT Fibrinogen HSGIS · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
| K913061 | Fibrinogen Determination KitGIS · Traditional | Sigma Diagnostics, Inc. | 10/09/1991SE |
| K910636 | Abs CadkitGIS · Traditional | Panbio, Inc. | 04/29/1991SE |
| K903874 | Fibrinotest(Tm) - Fibrinogen AssayGIS · Traditional | Haemachem, Inc. | 02/14/1991SE |
More from Haemachem, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| K841461 | Coagulation Control Plasma Level 1/2/3GGP · Traditional | 05/02/1984SE |
| K840802 | Dia Thrombin Dia PlastinGJS · Traditional | 05/01/1984SE |
Questions and answers
When was Fibrinogentest-O cleared by the FDA?
Fibrinogentest-O (K881685) received a 510(k) decision of Substantially Equivalent on August 9, 1988, 112 days after the submission was received.
What is the product code of K881685?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.