The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Cmv Igg Elisa.
| Device ID | K971335 |
| 510k Number | K971335 |
| Device Name: | QUANTA LITE CMV IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-12-01 |