Submission Details
| 510(k) Number | K082759 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 2008 |
| Decision Date | April 10, 2009 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
Apr 2009
Decision
200d
Days
Class 2
Risk
About This 510(k) Submission
K082759 is an FDA 510(k) clearance for the ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on April 10, 2009, 200 days after receiving the submission on September 22, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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