Cytotech C1-INHIBITOR Enzyme Immunoassay
FDA 510(k) K872426 · Cytotech, Inc.
510(k) numberK872426
Submission
- Device name
- Cytotech C1-INHIBITOR Enzyme Immunoassay
- Applicant
- Cytotech, Inc.
San Diego, CA, US - Received
- June 22, 1987
- Decision date
- July 23, 1987
- 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 |
| K821898 | Ortho Classical Pathway Compl. TestDBA · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1982SE |
More from Ortho Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882829 | Circulating Immune Complexes ControlsDAK · Traditional | 08/04/1988SE |
| K874379 | Cic-Raji Cell Replacement Enzyme ImmunoassayCZY · Traditional | 11/25/1987SE |
| K873249 | Antinuclear Antibody (Ana) Positive ControlsLKJ · Traditional | 09/22/1987SE |
| K871801 | Cytotech Antinuclear Antibody (Ana) Ifa KitDHN · Traditional | 06/09/1987SE |
| K864315 | Cytotech Rubella Igg Enzyme ImmunoassayLFX · Traditional | 02/02/1987SE |
| K862838 | Cytotech HSV Igg Enzyme ImmunoassayGCO · Traditional | 12/09/1986SE |
| K863363 | Cytotech Toxoplasma Igg Enzyme ImmunoassayLGD · Traditional | 11/13/1986SE |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | 09/04/1986SE |
| K860493 | Cytotech CMV Igg EiaGQI · Traditional | 05/20/1986SE |
Questions and answers
When was Cytotech C1-INHIBITOR Enzyme Immunoassay cleared by the FDA?
Cytotech C1-INHIBITOR Enzyme Immunoassay (K872426) received a 510(k) decision of Substantially Equivalent on July 23, 1987, 31 days after the submission was received.
What is the product code of K872426?
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.