510(k) K912852
K912852 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO". The FDA issued a decision of Substantially Equivalent on Sep 27, 1991. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 1991
- Date Received
- Jun 28, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type
- 510(k)