510(k) K991692
K991692 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS ACS: 180 FT3". The FDA issued a decision of Substantially Equivalent on Jun 18, 1999. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Chiron Diagnostics Corp. has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 1999
- Date Received
- May 18, 1999
- 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