Fibrinogen Determination Kit
FDA 510(k) K913061 · Sigma Diagnostics, Inc.
510(k) numberK913061
Submission
- Device name
- Fibrinogen Determination Kit
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- July 10, 1991
- Decision date
- October 9, 1991
- 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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| K042919 | Fibrotek FibGIS · Traditional | R2 Diagnostics, Inc. | 11/29/2004SE |
| 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 |
| 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 Fibrinogen Determination Kit cleared by the FDA?
Fibrinogen Determination Kit (K913061) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 91 days after the submission was received.
What is the product code of K913061?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.