Panels › Microbiology › Product code LJY · Class 1
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Regulation 866.3380
0510(k)s in 12 months (8 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corporation | 0 | 2 |
| Zeus Scientific, Inc. | 1 | 1 |
| bioMerieux, Inc. | 0 | 1 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Bion Enterprises Ltd | 0 | 1 |
| Biowhittaker Molecular Applications, Inc. | 1 | 0 |
| Calbiotech Inc | 0 | 1 |
| Columbia Bioscience, Inc. | 1 | 0 |
| Diasorin Inc. | 0 | 1 |
| Gull Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 1999 | K991274 | MUMPS IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | LJY |
| Apr 23, 1998 | K980059 | SERAQUEST MUMPS IGG Quest Intl., Inc. | LJY |
| Nov 4, 1997 | K971857 | MUMPS IGG ELISA TESTY Gull Laboratories, Inc. | LJY |
| Jul 18, 1996 | K961204 | MUMPS IGG TEST Zeus Scientific, Inc. | LJY |
| Oct 14, 1994 | K925209 | MUMPS STAT Biowhittaker Molecular Applications, Inc. | LJY |
| Aug 9, 1993 | K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA Biomerieux Vitek, Inc. | LJY |
| Jul 26, 1990 | K897006 | PHARMACIA MUMPS IGG ELISA Pharmacia Eni Diagnostics, Inc. | LJY |
| May 13, 1983 | K830045 | MUMPSELISA TEST KIT M.A. Bioproducts | LJY |
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