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 |