Alert A,Hdl-Apoliporotein a, Test Kit
FDA 510(k) K802610 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK802610
Submission
- Device name
- Alert A,Hdl-Apoliporotein a, Test Kit
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- October 21, 1980
- Decision date
- January 5, 1981
- 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 |
| K910553 | Roche Apolipoprotein StandardDER · Traditional | Roche Diagnostic Systems, Inc. | 05/08/1991SE |
More from Roche Diagnostic Systems, Inc.
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|---|---|---|
| K820835 | Alumina Silica-Activated Partial ThromGFO · Traditional | 04/26/1982SE |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | 03/11/1982SE |
| 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 |
| 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 |
| K780785 | Dilutor TransporterJQW · Traditional | 06/14/1978SE |
Questions and answers
When was Alert A,Hdl-Apoliporotein a, Test Kit cleared by the FDA?
Alert A,Hdl-Apoliporotein a, Test Kit (K802610) received a 510(k) decision of Substantially Equivalent on January 5, 1981, 76 days after the submission was received.
What is the product code of K802610?
The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.