K-Assay Fibrinogen
FDA 510(k) K993482 · Kamiya Biomedical Co.
510(k) numberK993482
Submission
- Device name
- K-Assay Fibrinogen
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- October 14, 1999
- Decision date
- December 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIS – Test, Fibrinogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code GIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control…GIS · Traditional | Diazyme Laboratories | 01/31/2016SE |
| K042919 | Fibrotek FibGIS · Traditional | R2 Diagnostics, Inc. | 11/29/2004SE |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | 04/18/2025SE |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | 05/20/2020SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Fibrinogen cleared by the FDA?
K-Assay Fibrinogen (K993482) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 53 days after the submission was received.
What is the product code of K993482?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.