Mumps Stat
FDA 510(k) K925209 · Biowhittaker Molecular Applications, Inc.
510(k) numberK925209
Submission
- Device name
- Mumps Stat
- Applicant
- Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US - Received
- October 7, 1992
- Decision date
- October 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | Gull Laboratories, Inc. | 11/04/1997SE |
| K961204 | Mumps Igg TestLJY · Traditional | Zeus Scientific, Inc. | 07/18/1996SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K943843 | Varicelisa, ModificationLFY · Traditional | 03/14/1996SE |
| K942361 | WhitsoftJJQ · Traditional | 04/04/1995SE |
| K942250 | Biowhittaker Cartridge Software for EIA-400 Plate ReaderJJQ · Traditional | 04/04/1995SE |
| K942245 | Biowhittaker 2001 Microplate Reader FirmwareJJQ · Traditional | 04/03/1995SE |
| K935618 | Specimen Transport MediumJSM · Traditional | 04/21/1994SE |
| K932679 | Rheumelisa II Histone Antibody Test KitLKJ · Traditional | 08/23/1993SE |
| K930757 | Rheumelisa II JO-1 Antibody Test KitLLL · Traditional | 03/26/1993SE |
| K930130 | Rheumelisa II SCL-70 Antibody Test KitLLL · Traditional | 03/23/1993SE |
| K920753 | RF Stat Igm Test KitDHR · Traditional | 03/30/1992SE |
Questions and answers
When was Mumps Stat cleared by the FDA?
Mumps Stat (K925209) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 737 days after the submission was received.
What is the product code of K925209?
The FDA product code is LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.