Submission Details
| 510(k) Number | K932662 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1993 |
| Decision Date | July 26, 1993 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Traditional
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
Jul 1993
Decision
54d
Days
Class 1
Risk
About This 510(k) Submission
K932662 is an FDA 510(k) clearance for the CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC 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 July 26, 1993, 54 days after receiving the submission on June 2, 1993. 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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