Fibrotek Fib
FDA 510(k) K042919 · R2 Diagnostics, Inc.
510(k) numberK042919
Submission
- Device name
- Fibrotek Fib
- Applicant
- R2 Diagnostics, Inc.
South Bend, IN, US - Received
- October 22, 2004
- Decision date
- November 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIS – Test, Fibrinogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
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|---|---|---|---|
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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 |
| K881685 | Fibrinogentest-OGIS · Traditional | Diatech, Inc. | 08/09/1988SE |
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Questions and answers
When was Fibrotek Fib cleared by the FDA?
Fibrotek Fib (K042919) received a 510(k) decision of Substantially Equivalent on November 29, 2004, 38 days after the submission was received.
What is the product code of K042919?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.