510(k) K844164
K844164 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "REACTIFS, IBF ULTROGELS ACA & ULTROGELS A". The FDA issued a decision of Substantially Equivalent on December 10, 1984. The device falls under product code DII (Columns, Glc), a Class I device regulated under 21 CFR 862.2250. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1984
- Date Received
- October 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Glc
- Device Class
- Class I
- Regulation Number
- 862.2250
- Review Panel
- TX
- Submission Type