510(k) K983617
K983617 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "25-HYDROXYVITAMIN D 125I RIA KIT". The FDA issued a decision of Substantially Equivalent on November 16, 1998. The device falls under product code LCI (Automated Radioimmunoassay Systems, For Clinical Use), a Class I device regulated under 21 CFR 862.2050. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1998
- Date Received
- October 15, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Radioimmunoassay Systems, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type