510(k) K973901
K973901 is an FDA 510(k) premarket notification submitted by Kmi Diagnostics, Inc. for the device "17 B-ESTRADIOL (ELISA)". The FDA issued a decision of Substantially Equivalent on November 24, 1997. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Kmi Diagnostics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1997
- Date Received
- October 14, 1997
- 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