510(k) K781728
K781728 is an FDA 510(k) premarket notification submitted by Analytichem International, Inc. for the device "EXTUBE". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code KEA (Resins, Ion-Exchange), 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
- December 20, 1978
- Date Received
- October 6, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resins, Ion-Exchange
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type