Ortho Bovine Albumin Solution 30% Prote
FDA 510(k) K802404 · Ortho Diagnostics, Inc.
510(k) numberK802404
Submission
- Device name
- Ortho Bovine Albumin Solution 30% Prote
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
Other 510(k)s with product code DCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153560 | Optilite Low Level Albumin KitDCF · Traditional | The Binding Site Group , Ltd. | 08/25/2016SE |
| K143118 | Human Microalbumin kit for use on SPAPLUSDCF · Traditional | The Binding Site Group , Ltd. | 05/26/2015SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | Beckman Coulter Ireland, Inc. | 10/15/2014SE |
| K121045 | Human Albumin CSF KitDCF · Traditional | The Binding Site Group , Ltd. | 06/19/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | Roche Diagnostics Operations | 05/14/2012SE |
| K101089 | Easyra Micro-Albumin Reagent and CalibratorDCF · Traditional | Medica Corp. | 07/13/2011SE |
| K101203 | Tina-Quant Albumin Gen 2DCF · Traditional | Roche Diagnostics | 09/10/2010SE |
| K100853 | Cobas 8000 Modular Series AnalyzerDCF · Special | Roche Diagnostics Corp. | 09/09/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | Kamiya Biomedical Co. | 04/29/2010SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | Beckman Coulter, Inc. | 04/08/2009SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | 12/04/1978SE |
Questions and answers
When was Ortho Bovine Albumin Solution 30% Prote cleared by the FDA?
Ortho Bovine Albumin Solution 30% Prote (K802404) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 17 days after the submission was received.
What is the product code of K802404?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.