510(k) K965109
K965109 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECSYS ESTRADIOL ASSAY". The FDA issued a decision of Substantially Equivalent on February 18, 1997. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1997
- Date Received
- December 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Estradiol
- Device Class
- Class I
- Regulation Number
- 862.1260
- Review Panel
- CH
- Submission Type