Submission Details
| 510(k) Number | K972819 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1997 |
| Decision Date | August 13, 1997 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
VIGIL TDM CONTROLS
Aug 1997
Decision
15d
Days
Class 1
Risk
About This 510(k) Submission
K972819 is an FDA 510(k) clearance for the VIGIL TDM CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 13, 1997, 15 days after receiving the submission on July 29, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.
Device Classification
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.3280 |
Manufacturer
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