The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite(tm) Igg (hrp).
| Device ID | K946034 |
| 510k Number | K946034 |
| Device Name: | QUANTA LITE(TM) IGG (HRP) |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-07-18 |