510(k) K994221
K994221 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "BAYER PSA ASSAY". The FDA issued a decision of Substantially Equivalent on April 13, 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. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2000
- Date Received
- December 15, 1999
- 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