K-Assay Apo B
FDA 510(k) K993354 · Kamiya Biomedical Co.
510(k) numberK993354
Submission
- Device name
- K-Assay Apo B
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- October 5, 1999
- Decision date
- October 28, 1999
- 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 |
| 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 |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| 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 |
|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | 04/18/2025SE |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional | 05/20/2020SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Apo B cleared by the FDA?
K-Assay Apo B (K993354) received a 510(k) decision of Substantially Equivalent on October 28, 1999, 23 days after the submission was received.
What is the product code of K993354?
The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.