Submission Details
| 510(k) Number | K072149 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 2007 |
| Decision Date | January 15, 2008 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
Jan 2008
Decision
165d
Days
Class 2
Risk
About This 510(k) Submission
K072149 is an FDA 510(k) clearance for the ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on January 15, 2008, 165 days after receiving the submission on August 3, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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