LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus Class I
FDA product code LJY covers "Enzyme Linked Immunoabsorbent Assay, Mumps Virus", a Class I medical device regulated under 21 CFR 866.3380. Submissions are reviewed by the Microbiology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LJY
- Device Class
- Class I
- Regulation Number
- 866.3380
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K991274 | Columbia Bioscience | MUMPS IGG ELISA TEST SYSTEM | Sep 3, 1999 |
| K980059 | Quest Intl | SERAQUEST MUMPS IGG | Apr 23, 1998 |
| K971857 | Gull Laboratories | MUMPS IGG ELISA TESTY | Nov 4, 1997 |
| K961204 | Zeus Scientific | MUMPS IGG TEST | Jul 18, 1996 |
| K925209 | Biowhittaker Molecular Applications | MUMPS STAT | Oct 14, 1994 |
| K923903 | Biomerieux Vitek | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | Aug 9, 1993 |
| K897006 | Pharmacia Eni Diagnostics | PHARMACIA MUMPS IGG ELISA | Jul 26, 1990 |
| K830045 | M.A. Bioproducts | MUMPSELISA TEST KIT | May 13, 1983 |