510(k) K872751
K872751 is an FDA 510(k) premarket notification submitted by Para Scientific Co. for the device "FLUORTRAN - C(TM)". The FDA issued a decision of Substantially Equivalent on July 23, 1987. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Para Scientific Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1987
- Date Received
- July 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type