510(k) K881361
K881361 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "SOLID PHASE EXTRACTION TUBES". The FDA issued a decision of Substantially Equivalent on August 8, 1988. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. Supelco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1988
- Date Received
- February 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ion-Exchange Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type