Submission Details
| 510(k) Number | K072257 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2007 |
| Decision Date | January 30, 2008 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Traditional
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
Jan 2008
Decision
170d
Days
Class 1
Risk
About This 510(k) Submission
K072257 is an FDA 510(k) clearance for the MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL, a Drug Specific Control Materials (Class I — General Controls, product code LAS), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on January 30, 2008, 170 days after receiving the submission on August 13, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.
Device Classification
| Product Code | LAS — Drug Specific Control Materials |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.3280 |
Manufacturer
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