Rubella Bio-Bead Screen Kit
FDA 510(k) K791610 · Litton Bionetics
510(k) numberK791610
Submission
- Device name
- Rubella Bio-Bead Screen Kit
- Applicant
- Litton Bionetics
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- November 13, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOL – Antigen, Ha (Including Ha Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | Intl. Diagnostic Technology | 06/07/1984SE |
| K834032 | Rubaquick Diagnostic KitGOL · Traditional | Abbott Laboratories | 04/17/1984SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | Calbiochem-Behring Corp. | 03/11/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | M.A. Bioproducts | 12/18/1980SE |
| K802339 | Eia Rubella-GGOL · Traditional | Beckman Instruments, Inc. | 12/18/1980SE |
| K802102 | Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional | Calbiochem-Behring Corp. | 12/18/1980SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | Clinical Assays, Inc. | 10/23/1980SE |
| K801098 | Enzyme-Immunoassay (Rubella Antibodies)GOL · Traditional | Flow Laboratories, Inc. | 09/16/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | Ortho Diagnostics, Inc. | 08/20/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | Litton Bionetics | 06/30/1980SE |
More from Litton Bionetics
| 510(k) | Device | Decision |
|---|---|---|
| K840417 | Ebna Acif KitLLM · Traditional | 12/27/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | 03/16/1984SE |
| K831343 | CMV RQ Bio-Enzabead KitLFZ · Traditional | 08/08/1983SE |
| K822985 | Ebv-M KitJRY · Traditional | 12/03/1982SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | 09/14/1982SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | 09/16/1980SE |
| K801721 | HSV Bio-Bead Titration KitGQN · Traditional | 09/16/1980SE |
| K801720 | Toxo Bio-Bead Titration KitGLZ · Traditional | 09/16/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | 06/30/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
Questions and answers
When was Rubella Bio-Bead Screen Kit cleared by the FDA?
Rubella Bio-Bead Screen Kit (K791610) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 84 days after the submission was received.
What is the product code of K791610?
The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.