Submission Details
| 510(k) Number | K033809 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 08, 2003 |
| Decision Date | February 20, 2004 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
Feb 2004
Decision
74d
Days
Class 2
Risk
About This 510(k) Submission
K033809 is an FDA 510(k) clearance for the DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 20, 2004, 74 days after receiving the submission on December 8, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3555.
Device Classification
| Product Code | KLR — Enzyme Immunoassay, Lidocaine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3555 |
Manufacturer
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