Thrombokinetic Fibrinogen Assay
FDA 510(k) K792563 · Bio/Data Corp.
510(k) numberK792563
Submission
- Device name
- Thrombokinetic Fibrinogen Assay
- Applicant
- Bio/Data Corp.
Mchenry, IL, US - Received
- December 12, 1979
- Decision date
- January 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQJ – System, Fibrinogen Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code KQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ · Special | Instrumentation Laboratory (IL) Co. | 07/24/2025SE |
| K073367 | Hemosil Fibrinogen-CKQJ · Special | Instrumentation Laboratory CO | 12/27/2007SE |
| K050928 | Dade Thrombin ReagentKQJ · Traditional | Dade Behring, Inc. | 06/29/2005SE |
| K971858 | Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional | Sigma Diagnostics, Inc. | 10/09/1997SE |
| K970189 | Fif TMKQJ · Traditional | Panbio, Inc. | 05/21/1997SE |
| K965113 | N-Assay Tia Fibrinogen Test KitKQJ · Traditional | Crestat Diagnostics, Inc. | 04/16/1997SE |
| K934326 | Multifibren UKQJ · Traditional | Behring Diagnostics, Inc. | 04/19/1994SE |
| K931721 | Il Test Fibrinogen-CKQJ · Traditional | Instrumentation Laboratory CO | 08/13/1993SE |
| K922416 | Fibrinogen Rid Test KitKQJ · Traditional | The Binding Site, Ltd. | 03/09/1993SE |
| K925988 | MultifibrenKQJ · Traditional | Behring Diagnostics, Inc. | 03/01/1993SE |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001891 | Microsample Coagulation Analyzer, Model Mca 310-CGKP · Special | 07/12/2000SE |
| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | 03/24/1995SE |
| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| 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 |
Questions and answers
When was Thrombokinetic Fibrinogen Assay cleared by the FDA?
Thrombokinetic Fibrinogen Assay (K792563) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 30 days after the submission was received.
What is the product code of K792563?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.