Submission Details
| 510(k) Number | K072393 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2007 |
| Decision Date | December 07, 2007 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Dec 2007
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K072393 is an FDA 510(k) clearance for the ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on December 7, 2007, 102 days after receiving the submission on August 27, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LSW — Anti-dna Antibody, Antigen And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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