510(k) K791651
K791651 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "TOTAL ESTROGENS KIT BY RIA". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code JMD (Radioimmunoassay, Total Estrogens, Nonpregnancy), a Class I device regulated under 21 CFR 862.1275. Radioassay Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1979
- Date Received
- August 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Total Estrogens, Nonpregnancy
- Device Class
- Class I
- Regulation Number
- 862.1275
- Review Panel
- CH
- Submission Type