510(k) K790630
K790630 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RIA, INSULIN, DOUBLE ANTIBODY". The FDA issued a decision of Substantially Equivalent on Jul 24, 1979. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Endocrine-Metabolic Center has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 1979
- Date Received
- Mar 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Immunoreactive Insulin
- Device Class
- Class I
- Regulation Number
- 862.1405
- Review Panel
- CH
- Submission Type
- 510(k) Exempt