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 | September 3, 1999 |
| K980059 | quest intl | SERAQUEST MUMPS IGG | April 23, 1998 |
| K971857 | gull laboratories | MUMPS IGG ELISA TESTY | November 4, 1997 |
| K961204 | zeus scientific | MUMPS IGG TEST | July 18, 1996 |
| K925209 | biowhittaker molecular applications | MUMPS STAT | October 14, 1994 |
| K923903 | biomerieux vitek | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | August 9, 1993 |
| K897006 | pharmacia eni diagnostics | PHARMACIA MUMPS IGG ELISA | July 26, 1990 |
| K830045 | m.a. bioproducts | MUMPSELISA TEST KIT | May 13, 1983 |