Ortho Quantitative Fibrinogen Assay
FDA 510(k) K810058 · Ortho Diagnostic Systems, Inc.
510(k) numberK810058
Submission
- Device name
- Ortho Quantitative Fibrinogen Assay
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- January 13, 1981
- Decision date
- February 26, 1981
- 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 |
|---|---|---|
| K951459 | Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional | 07/14/1997SE |
| K951632 | Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional | 03/06/1997SE |
| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | 01/22/1997SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | 11/29/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
Questions and answers
When was Ortho Quantitative Fibrinogen Assay cleared by the FDA?
Ortho Quantitative Fibrinogen Assay (K810058) received a 510(k) decision of Substantially Equivalent on February 26, 1981, 44 days after the submission was received.
What is the product code of K810058?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.