510(k) K923021
K923021 is an FDA 510(k) premarket notification submitted by Tosoh Corp. for the device "AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 1992. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Tosoh Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1992
- Date Received
- June 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometer, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2560
- Review Panel
- CH
- Submission Type