N-Assay Tia Apo B Test Kit
FDA 510(k) K964296 · Crestat Diagnostics, Inc.
510(k) numberK964296
Submission
- Device name
- N-Assay Tia Apo B Test Kit
- Applicant
- Crestat Diagnostics, Inc.
Murrieta, CA, US - Received
- October 29, 1996
- Decision date
- August 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5580
- Specialty
- Immunology
Other 510(k)s with product code DER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013249 | Tina-Quant Apolipoprotein VER.2DER · Traditional | Roche Diagnostics Corp. | 11/16/2001SE |
| K000921 | Bayer Advia Ims System; 200 + 3DER · Traditional | Bayer Corp. | 05/18/2000SE |
| K993354 | K-Assay Apo BDER · Traditional | Kamiya Biomedical Co. | 10/28/1999SE |
| K993345 | K-Assay Apo AiDER · Traditional | Kamiya Biomedical Co. | 10/25/1999SE |
| K990594 | Integra Reagent Cassette for Apolipoprotein A-1DER · Traditional | Roche Diagnostics Corp. | 04/14/1999SE |
| K983289 | Apolipoprotein A1DER · Traditional | Abbott Laboratories | 01/29/1999SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| K910553 | Roche Apolipoprotein StandardDER · Traditional | Roche Diagnostic Systems, Inc. | 05/08/1991SE |
| K904125 | Uc Imu aDER · Traditional | Eucardio Laboratory, Inc. | 09/24/1990SE |
More from Eucardio Laboratory, 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 |
| 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 |
| K965100 | N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional | 07/14/1997SE |
Questions and answers
When was N-Assay Tia Apo B Test Kit cleared by the FDA?
N-Assay Tia Apo B Test Kit (K964296) received a 510(k) decision of Substantially Equivalent on August 1, 1997, 276 days after the submission was received.
What is the product code of K964296?
The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.