510(k) K002313
K002313 is an FDA 510(k) premarket notification submitted by Oncogene Science, Inc. for the device "COMPLEXED PSA MICROTITER ELISA". The FDA issued a decision of Substantially Equivalent on August 30, 2000. 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. Oncogene Science, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2000
- Date Received
- July 31, 2000
- Clearance Type
- Traditional
- 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