The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Pelicalss Human Igg Subclass Nephlometric Array Kit.
| Device ID | K982023 |
| 510k Number | K982023 |
| Device Name: | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT |
| Classification | Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| 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 | DAS |
| CFR Regulation Number | 866.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-09 |
| Decision Date | 1998-09-04 |