Rubelisa Igm Test Kit
FDA 510(k) K802508 · M.A. Bioproducts
510(k) numberK802508
Submission
- Device name
- Rubelisa Igm Test Kit
- Applicant
- M.A. Bioproducts
Walker, MI, US - Received
- October 15, 1980
- Decision date
- December 18, 1980
- 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 |
| 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 |
| K800797 | Macro-Vue Rubella Card TestGOL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/20/1980SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K823804 | Mycoplasmelisa Test KitLJZ · Traditional | 05/25/1983SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | 05/13/1983SE |
| K830615 | Cytomegelisa StatLFZ · Traditional | 05/09/1983SE |
| K823805 | Varicelisa Test KitLFY · Traditional | 05/05/1983SE |
| K821967 | Chlamydelisa Test KitLJC · Traditional | 08/03/1982SE |
| K821762 | Measelisa Test KitLJB · Traditional | 07/30/1982SE |
| K813221 | Toxoelisa Test KitLGD · Traditional | 01/26/1982SE |
| K812531 | Cell Culture ReagentsKIT · Traditional | 10/23/1981SE |
| K812123 | Cytomegelisa Test Kit · Traditional | 09/23/1981SE |
Questions and answers
When was Rubelisa Igm Test Kit cleared by the FDA?
Rubelisa Igm Test Kit (K802508) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 64 days after the submission was received.
What is the product code of K802508?
The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.