510(k) K832198
K832198 is an FDA 510(k) premarket notification submitted by Hamilton Co. for the device "HC40/HC75 PREPACKED COLUMS". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. Hamilton Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- July 7, 1983
- 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