QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1)
INOVA DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash® Lkm-1 Reagents, Quanta Flash® Lkm-1 Calibrators, Quanta Flash® Lkm-1 Controls.
Pre-market Notification Details
| Device ID | K163538 |
| 510k Number | K163538 |
| Device Name: | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls |
| Classification | Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Contact | Roger Albesa |
| Correspondent | Ronda Elliott INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Product Code | NBS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-09-06 |
| Summary: | summary |
Trademark Results [QUANTA Flash]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTA FLASH 77963733 4071260 Live/Registered |
Inova Diagnostics, Inc. 2010-03-19 |
 QUANTA FLASH 77729358 4067677 Live/Registered |
Inova Diagnostics, Inc. 2009-05-05 |
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