Roche Apolipoprotein Standard
FDA 510(k) K910553 · Roche Diagnostic Systems, Inc.
510(k) numberK910553
Submission
- Device name
- Roche Apolipoprotein Standard
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- February 7, 1991
- Decision date
- May 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K904125 | Uc Imu aDER · Traditional | Eucardio Laboratory, Inc. | 09/24/1990SE |
More from Eucardio Laboratory, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Roche Apolipoprotein Standard cleared by the FDA?
Roche Apolipoprotein Standard (K910553) received a 510(k) decision of Substantially Equivalent on May 8, 1991, 90 days after the submission was received.
What is the product code of K910553?
The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.