510(k) K791497
K791497 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "PROSTATIC ACID RADIOIMMUNOASSAY TEST". The FDA issued a decision of Substantially Equivalent on December 4, 1979. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1979
- Date Received
- August 3, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase (Prostatic), Tartrate Inhibited
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type