Mumpselisa Test Kit
FDA 510(k) K830045 · M.A. Bioproducts
510(k) numberK830045
Submission
- Device name
- Mumpselisa Test Kit
- Applicant
- M.A. Bioproducts
Walker, MI, US - Received
- January 10, 1983
- Decision date
- May 13, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3380
- Specialty
- Microbiology
Other 510(k)s with product code LJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | Columbia Bioscience, Inc. | 09/03/1999SE |
| K980059 | Seraquest Mumps IggLJY · Traditional | Quest Intl., Inc. | 04/23/1998SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | Gull Laboratories, Inc. | 11/04/1997SE |
| K961204 | Mumps Igg TestLJY · Traditional | Zeus Scientific, Inc. | 07/18/1996SE |
| K925209 | Mumps StatLJY · Traditional | Biowhittaker Molecular Applications, Inc. | 10/14/1994SE |
| K923903 | Vitek Immunodiagnostic Assay System Mumps Igg AssaLJY · Traditional | Biomerieux Vitek, Inc. | 08/09/1993SE |
| K897006 | Pharmacia Mumps Igg ElisaLJY · Traditional | Pharmacia Eni Diagnostics, Inc. | 07/26/1990SE |
More from Pharmacia Eni Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K823804 | Mycoplasmelisa Test KitLJZ · Traditional | 05/25/1983SE |
| 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 |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | 12/18/1980SE |
Questions and answers
When was Mumpselisa Test Kit cleared by the FDA?
Mumpselisa Test Kit (K830045) received a 510(k) decision of Substantially Equivalent on May 13, 1983, 123 days after the submission was received.
What is the product code of K830045?
The FDA product code is LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.