Mumps Igg Elisa Test System
FDA 510(k) K991274 · Columbia Bioscience, Inc.
510(k) numberK991274
Submission
- Device name
- Mumps Igg Elisa Test System
- Applicant
- Columbia Bioscience, Inc.
Columbia, MD, US - Received
- April 13, 1999
- Decision date
- September 3, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K830045 | Mumpselisa Test KitLJY · Traditional | M.A. Bioproducts | 05/13/1983SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | 09/03/1999SE |
| K984228 | Is Anti-Tpo Igg Elisa Test SystemJZO · Traditional | 02/02/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | 12/16/1998SE |
| K983605 | Is Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 12/16/1998SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K983740 | IS-ANTI-PR3 Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
| K983390 | Is-Anti-Mpo Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
Questions and answers
When was Mumps Igg Elisa Test System cleared by the FDA?
Mumps Igg Elisa Test System (K991274) received a 510(k) decision of Substantially Equivalent on September 3, 1999, 143 days after the submission was received.
What is the product code of K991274?
The FDA product code is LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.