Las-R Human C1 Esterase Inhibitor Test
FDA 510(k) K780335 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK780335
Submission
- Device name
- Las-R Human C1 Esterase Inhibitor Test
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- February 28, 1978
- Decision date
- March 22, 1978
- 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
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| 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 |
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| K820835 | Alumina Silica-Activated Partial ThromGFO · Traditional | 04/26/1982SE |
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| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | 08/18/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
Questions and answers
When was Las-R Human C1 Esterase Inhibitor Test cleared by the FDA?
Las-R Human C1 Esterase Inhibitor Test (K780335) received a 510(k) decision of Substantially Equivalent on March 22, 1978, 22 days after the submission was received.
What is the product code of K780335?
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.