Rubindex*Direct System
FDA 510(k) K781638 · Ortho Diagnostics, Inc.
510(k) numberK781638
Submission
- Device name
- Rubindex*Direct System
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- September 21, 1978
- Decision date
- December 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOK – Antisera, Hai (Including Hai Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832228 | Rubascan Latex Card TestGOK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/29/1983SE |
| K810835 | Rubazyme - MGOK · Traditional | Abbott Laboratories | 05/05/1981SE |
| K792635 | Antibody to Rubella VirusGOK · Traditional | Electro-Nucleonics Laboratories, Inc. | 03/19/1980SE |
| K792133 | Rubelisa Test KitGOK · Traditional | Microbiological Assoc. | 01/11/1980SE |
| K790122 | RubanonGOK · Traditional | Organon, Inc. | 02/15/1979SE |
| K781392 | Cytomegilish Test KitGOK · Traditional | Microbiological Assoc. | 10/24/1978SE |
| K780063 | RubenosticonGOK · Traditional | Organon, Inc. | 01/20/1978SE |
| K780010 | Goat Anti-Rubella AntiseraGOK · Traditional | Northeast Biomedical Labs., Inc. | 01/20/1978SE |
| K771957 | Rubella Hemagglutination Reagent KitGOK · Traditional | Flow Laboratories, Inc. | 10/28/1977SE |
| K771956 | Human O BufferGOK · Traditional | Flow Laboratories, Inc. | 10/28/1977SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| 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 |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | 12/04/1978SE |
Questions and answers
When was Rubindex*Direct System cleared by the FDA?
Rubindex*Direct System (K781638) received a 510(k) decision of Substantially Equivalent on December 20, 1978, 90 days after the submission was received.
What is the product code of K781638?
The FDA product code is GOK – Antisera, Hai (Including Hai Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.