510(k) K850053
K850053 is an FDA 510(k) premarket notification submitted by Euro-Diagnostics BV for the device "BACI 6 -ADRENOCORTICOTROOP HORMONE". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Euro-Diagnostics BV has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1985
- Date Received
- January 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type