N Antiserum to C1 Inhibitor
FDA 510(k) K960257 · Behring Diagnostics, Inc.
510(k) numberK960257
Submission
- Device name
- N Antiserum to C1 Inhibitor
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- January 18, 1996
- Decision date
- August 1, 1996
- 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 |
| 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 |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was N Antiserum to C1 Inhibitor cleared by the FDA?
N Antiserum to C1 Inhibitor (K960257) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 196 days after the submission was received.
What is the product code of K960257?
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.