510(k) K791079
K791079 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "GAMMADAB (125 1) FOLATE RADIOASSAY KIT". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1979
- Date Received
- June 12, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type