The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Rubeola (measles) Igg.
| Device ID | K971620 |
| 510k Number | K971620 |
| Device Name: | QUANTA LITE RUBEOLA (MEASLES) IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| 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 | LJB |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-22 |