Pharmacia Mumps Igg Elisa
FDA 510(k) K897006 · Pharmacia Eni Diagnostics, Inc.
510(k) numberK897006
Submission
- Device name
- Pharmacia Mumps Igg Elisa
- Applicant
- Pharmacia Eni Diagnostics, Inc.
Columbia, MD, US - Received
- December 18, 1989
- Decision date
- July 26, 1990
- 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 |
| K830045 | Mumpselisa Test KitLJY · Traditional | M.A. Bioproducts | 05/13/1983SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K894503 | Gemtab SystemJJQ · Traditional | 09/05/1989SE |
Questions and answers
When was Pharmacia Mumps Igg Elisa cleared by the FDA?
Pharmacia Mumps Igg Elisa (K897006) received a 510(k) decision of Substantially Equivalent on July 26, 1990, 220 days after the submission was received.
What is the product code of K897006?
The FDA product code is LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.