Kinetic Fibrinogen Assay
FDA 510(k) K881150 · Bio/Data Corp.
510(k) numberK881150
Submission
- Device name
- Kinetic Fibrinogen Assay
- Applicant
- Bio/Data Corp.
Hatboro, PA, US - Received
- March 17, 1988
- Decision date
- March 28, 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
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 |
| 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.
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|---|---|---|
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| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | 11/20/1987SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
| K853078 | Citrex IIIJPA · Traditional | 08/12/1985SE |
Questions and answers
When was Kinetic Fibrinogen Assay cleared by the FDA?
Kinetic Fibrinogen Assay (K881150) received a 510(k) decision of Substantially Equivalent on March 28, 1988, 11 days after the submission was received.
What is the product code of K881150?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.