Rubascan Latex Card Test
FDA 510(k) K832228 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK832228
Submission
- Device name
- Rubascan Latex Card Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- July 11, 1983
- Decision date
- September 29, 1983
- 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 |
|---|---|---|---|
| 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 |
| K781638 | Rubindex*Direct SystemGOK · Traditional | Ortho Diagnostics, Inc. | 12/20/1978SE |
| 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 |
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Questions and answers
When was Rubascan Latex Card Test cleared by the FDA?
Rubascan Latex Card Test (K832228) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 80 days after the submission was received.
What is the product code of K832228?
The FDA product code is GOK – Antisera, Hai (Including Hai Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.