N-Assay Tia Multi V-Nl
FDA 510(k) K964300 · Crestat Diagnostics, Inc.
510(k) numberK964300
Submission
- Device name
- N-Assay Tia Multi V-Nl
- Applicant
- Crestat Diagnostics, Inc.
Murrieta, CA, US - Received
- October 29, 1996
- Decision date
- July 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBI – Complement C4, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code DBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100455 | Spaplus AnalyzerDBI · Traditional | The Binding Site | 09/03/2010SE |
| K012359 | Tina-Quant Complement C4 Test SystemDBI · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010325 | Wako Autokit C4DBI · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000468 | Randox Complement C4DBI · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
| K994293 | Dimension C4 Flex Reagent CartridgeDBI · Traditional | Dade Behring, Inc. | 03/01/2000SE |
| K981785 | C4 Minineph AntiserumDBI · Traditional | The Binding Site, Ltd. | 12/20/1999SE |
| K993481 | K-Assay C4DBI · Traditional | Kamiya Biomedical Co. | 11/29/1999SE |
| K983356 | C4DBI · Traditional | Abbott Laboratories | 11/04/1998SE |
| K964297 | N-Assay Tia C4 Test KitDBI · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K962582 | Olympus C4 Immunoturbidimetric ReagentDBI · Traditional | Olympus America, Inc. | 10/18/1996SE |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980883 | N-Assay Glu-UlCFR · Traditional | 09/03/1998SE |
| K981276 | N-Assay L D-BilCIG · Traditional | 05/01/1998SE |
| K981289 | N-Assay L T-BilCIG · Traditional | 04/27/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | 03/26/1998SE |
| K980900 | N-Assay Cpk-LCGS · Traditional | 03/26/1998SE |
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | 10/20/1997SE |
| K971985 | N-Assay Tia Plasminogen Test KitGGP · Traditional | 10/20/1997SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | 08/01/1997SE |
Questions and answers
When was N-Assay Tia Multi V-Nl cleared by the FDA?
N-Assay Tia Multi V-Nl (K964300) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 258 days after the submission was received.
What is the product code of K964300?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.