The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Gp210 Elisa.
Device ID | K040885 |
510k Number | K040885 |
Device Name: | QUANTA LITE GP210 ELISA |
Classification | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
Contact | Gary L Norman |
Correspondent | Gary L Norman INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
Product Code | NRI |
CFR Regulation Number | 866.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-05 |
Decision Date | 2004-06-25 |