510(k) K800061
K800061 is an FDA 510(k) premarket notification submitted by Analytichem International, Inc. for the device "BOND ELUT COLUMNS". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. Analytichem International, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1980
- Date Received
- January 9, 1980
- 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