Submission Details
| 510(k) Number | K042407 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2004 |
| Decision Date | October 28, 2004 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
EMIT CAFFEINE ASSAY
Oct 2004
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K042407 is an FDA 510(k) clearance for the EMIT CAFFEINE ASSAY, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on October 28, 2004, 55 days after receiving the submission on September 3, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.
Device Classification
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3880 |
Manufacturer
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