Apo-Screen Test Set for Hdl-Apolipoptein A-1
FDA 510(k) K853048 · Photec Diagnostics, Inc.
510(k) numberK853048
Submission
- Device name
- Apo-Screen Test Set for Hdl-Apolipoptein A-1
- Applicant
- Photec Diagnostics, Inc.
Little Falls, NJ, US - Received
- July 19, 1985
- Decision date
- August 28, 1985
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K897169 | Quikread(R) Whole Blood Triglyceride Test KitCDT · Traditional | 02/23/1990SE |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | 12/12/1989SE |
| K894057 | Quikread Whole Blood Hdl-Cholesterol Test KitLBS · Traditional | 08/31/1989SE |
| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | 04/26/1989SE |
| K882307 | D-ChemJJE · Traditional | 08/02/1988SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
Questions and answers
When was Apo-Screen Test Set for Hdl-Apolipoptein A-1 cleared by the FDA?
Apo-Screen Test Set for Hdl-Apolipoptein A-1 (K853048) received a 510(k) decision of Substantially Equivalent on August 28, 1985, 40 days after the submission was received.
What is the product code of K853048?
The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.