The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Mumps Igg Elisa Testy.
| Device ID | K971857 |
| 510k Number | K971857 |
| Device Name: | MUMPS IGG ELISA TESTY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Applicant | GULL LABORATORIES, INC. 1011 MURRAY HOLLADAY RD. Salt Lake City, UT 84117 |
| Contact | Fred W Rachford |
| Correspondent | Fred W Rachford GULL LABORATORIES, INC. 1011 MURRAY HOLLADAY RD. Salt Lake City, UT 84117 |
| Product Code | LJY |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1997-11-04 |
| Summary: | summary |