The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite H-ttg Screen.
Device ID | K073145 |
510k Number | K073145 |
Device Name: | QUANTA LITE H-TTG SCREEN |
Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
Contact | Joseph Phillips |
Correspondent | Joseph Phillips INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
Product Code | MVM |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-08 |
Decision Date | 2008-02-12 |
Summary: | summary |