The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Actin (anti-smooth Muscle) Elisa.
| Device ID | K021648 |
| 510k Number | K021648 |
| Device Name: | QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA |
| Classification | Antibodies, Anti-actin, Anti-smooth Muscle |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | NJF |
| CFR Regulation Number | 866.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-09-20 |