The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Sla (soluble Liver Antigen) Elisa.
Device ID | K021482 |
510k Number | K021482 |
Device Name: | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA |
Classification | Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 -1234 |
Contact | Brys C Myers |
Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 -1234 |
Product Code | NIY |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-08 |
Decision Date | 2002-07-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950593706 | K021482 | 000 |