510(k) K791999
K791999 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "(125I) TESTOSTERONE KIT". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Radioassay Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1979
- Date Received
- October 5, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type