Submission Details
| 510(k) Number | K040445 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 20, 2004 |
| Decision Date | May 19, 2004 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
May 2004
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K040445 is an FDA 510(k) clearance for the ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 19, 2004, 89 days after receiving the submission on February 20, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.
Device Classification
| Product Code | JXN — Enzyme Immunoassay, Propoxyphene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3700 |
Manufacturer
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