510(k) K843505
K843505 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "LKB 2230 ROTARY ONE". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code IDO (Microtome, Rotary), a Class I device regulated under 21 CFR 864.3010. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1984
- Date Received
- September 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtome, Rotary
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type