The following data is part of a premarket notification filed by Pharmacia Eni Diagnostics, Inc. with the FDA for Pharmacia Mumps Igg Elisa.
| Device ID | K897006 |
| 510k Number | K897006 |
| Device Name: | PHARMACIA MUMPS IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Applicant | PHARMACIA ENI DIAGNOSTICS, INC. 8310 GUILFORD RD. SUITE E Columbia, MD 21046 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy PHARMACIA ENI DIAGNOSTICS, INC. 8310 GUILFORD RD. SUITE E Columbia, MD 21046 |
| Product Code | LJY |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747110 | K897006 | 000 |
| 05391516743600 | K897006 | 000 |