Submission Details
| 510(k) Number | K031343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 29, 2003 |
| Decision Date | May 15, 2003 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Special
TPSA FLEX REAGENT CARTRIDGE
May 2003
Decision
16d
Days
Class 2
Risk
About This 510(k) Submission
K031343 is an FDA 510(k) clearance for the TPSA FLEX REAGENT CARTRIDGE, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 15, 2003, 16 days after receiving the submission on April 29, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.
Device Classification
| Product Code | LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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