510(k) K910249
K910249 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS ESTRADIOL FLUOREMETRIC ENZYME". The FDA issued a decision of Substantially Equivalent on Feb 13, 1991. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1991
- Date Received
- Jan 22, 1991
- 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
- 510(k) Exempt