510(k) K884403
K884403 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code DPM (Columns, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Supelco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1988
- Date Received
- October 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Liquid Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type