The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash H-ttg Igg.
| Device ID | K101644 |
| 510k Number | K101644 |
| Device Name: | QUANTA FLASH H-TTG IGG |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Rufus Burlingame |
| Correspondent | Rufus Burlingame INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | MVM |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2011-03-23 |