C1-INHIBITOR Microtiter Assay Device
FDA 510(k) K003747 · Baxter Healthcare Corp
510(k) numberK003747
Submission
- Device name
- C1-INHIBITOR Microtiter Assay Device
- Applicant
- Baxter Healthcare Corp
Glendale, CA, US - Received
- December 4, 2000
- Decision date
- March 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K821898 | Ortho Classical Pathway Compl. TestDBA · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1982SE |
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Questions and answers
When was C1-INHIBITOR Microtiter Assay Device cleared by the FDA?
C1-INHIBITOR Microtiter Assay Device (K003747) received a 510(k) decision of Substantially Equivalent on March 19, 2001, 105 days after the submission was received.
What is the product code of K003747?
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.