The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Aca Igm (hrp).
Device ID | K946385 |
510k Number | K946385 |
Device Name: | QUANTA LITE ACA IGM (HRP) |
Classification | System, Test, Anticardiolipin Immunological |
Applicant | INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego, CA 92121 |
Contact | Byrs C Myers |
Correspondent | Byrs 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 |