510(k) K800187
K800187 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "EMC-M-175, THYROXINE - 100 TUBES". The FDA issued a decision of Substantially Equivalent on Feb 13, 1980. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Endocrine-Metabolic Center has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1980
- Date Received
- Jan 29, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Total Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1700
- Review Panel
- CH
- Submission Type
- 510(k) Exempt