510(k) K883479
K883479 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME". The FDA issued a decision of Substantially Equivalent on Oct 25, 1988. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 1988
- Date Received
- Aug 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Total Triiodothyronine
- Device Class
- Class II
- Regulation Number
- 862.1710
- Review Panel
- CH
- Submission Type
- 510(k) Exempt