Ortho Classical Pathway Compl. Test
FDA 510(k) K821898 · Ortho Diagnostic Systems, Inc.
510(k) numberK821898
Submission
- Device name
- Ortho Classical Pathway Compl. Test
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- June 28, 1982
- Decision date
- July 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBA – Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5250
- Specialty
- Immunology
Other 510(k)s with product code DBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141100 | Optilite C1 Inactivator KitDBA · Traditional | The Binding Site Group , Ltd. | 07/18/2014SE |
| K122304 | Human C1 Inactivator Kit for Use on SpaplusDBA · Traditional | The Binding Site Group , Ltd. | 04/15/2013SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | Dade Behring, Inc. | 12/21/2007SE |
| K011780 | K-Assay C1-INADBA · Traditional | Kamiya Biomedical Co. | 07/25/2001SE |
| K003747 | C1-INHIBITOR Microtiter Assay DeviceDBA · Traditional | Baxter Healthcare Corp | 03/19/2001SE |
| K965024 | N-Assay Tia C1-INACTIVATOR Test KitDBA · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K960257 | N Antiserum to C1 InhibitorDBA · Traditional | Behring Diagnostics, Inc. | 08/01/1996SE |
| K951967 | Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| K915431 | Complement C1 Inactivator KitDBA · Traditional | The Binding Site, Ltd. | 01/17/1992SE |
| K872426 | Cytotech C1-INHIBITOR Enzyme ImmunoassayDBA · Traditional | Cytotech, Inc. | 07/23/1987SE |
More from Cytotech, 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 Classical Pathway Compl. Test cleared by the FDA?
Ortho Classical Pathway Compl. Test (K821898) received a 510(k) decision of Substantially Equivalent on July 16, 1982, 18 days after the submission was received.
What is the product code of K821898?
The FDA product code is DBA – Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5250.