Cytomegelisa Test Kit
FDA 510(k) K812123 · M.A. Bioproducts
510(k) numberK812123
Submission
- Device name
- Cytomegelisa Test Kit
- Applicant
- M.A. Bioproducts
Mchenry, IL, US - Received
- July 27, 1981
- Decision date
- September 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from M.A. Bioproducts
| 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 |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | 12/18/1980SE |
Questions and answers
When was Cytomegelisa Test Kit cleared by the FDA?
Cytomegelisa Test Kit (K812123) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 58 days after the submission was received.