510(k) K953567
K953567 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "INCSTAR 25-HYDROXYVITMIN D 1251 RIA". The FDA issued a decision of Substantially Equivalent on September 25, 1996. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Incstar Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1996
- Date Received
- July 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Vitamin D
- Device Class
- Class II
- Regulation Number
- 862.1825
- Review Panel
- CH
- Submission Type