510(k) K840301
K840301 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIANEN ESTRIOL RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. New England Nuclear has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1984
- Date Received
- January 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Estriol
- Device Class
- Class I
- Regulation Number
- 862.1265
- Review Panel
- CH
- Submission Type