510(k) K031343
K031343 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "TPSA FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on May 15, 2003. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2003
- Date Received
- April 29, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type