510(k) K813575
K813575 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "LIQUID CHROMATOGRAPHY (HPLC) COLUMNS". The FDA issued a decision of Substantially Equivalent on January 18, 1982. 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
- January 18, 1982
- Date Received
- December 23, 1981
- 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