K982023 is an FDA 510(k) clearance for the PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT. This device is classified as a Igg (fc Fragment Specific), Antigen, Antiserum, Control (Class I - General Controls, product code DAS).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 1998, 87 days after receiving the submission on June 9, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5530.
| 510(k) Number | K982023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1998 |
| Decision Date | September 04, 1998 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DAS — Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5530 |