The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Mumps Igg Test.
| Device ID | K961204 |
| 510k Number | K961204 |
| Device Name: | MUMPS IGG TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LJY |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-27 |
| Decision Date | 1996-07-18 |