510(k) K994419
K994419 is an FDA 510(k) premarket notification submitted by Qualisys Diagnostics, Inc. for the device "FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 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. Qualisys Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2000
- Date Received
- December 29, 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