Mumps Igg Elisa Testy
FDA 510(k) K971857 · Gull Laboratories, Inc.
510(k) numberK971857
Submission
- Device name
- Mumps Igg Elisa Testy
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- May 20, 1997
- Decision date
- November 4, 1997
- 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 |
|---|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | Columbia Bioscience, Inc. | 09/03/1999SE |
| K980059 | Seraquest Mumps IggLJY · Traditional | Quest Intl., Inc. | 04/23/1998SE |
| 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 |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
| K922758 | HSV-1 Igm Elisa Test -- ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Mumps Igg Elisa Testy cleared by the FDA?
Mumps Igg Elisa Testy (K971857) received a 510(k) decision of Substantially Equivalent on November 4, 1997, 168 days after the submission was received.
What is the product code of K971857?
The FDA product code is LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.