510(k) K812157

LKB-BROMMA 2218 HISTORANGE MICROTOME by Lkb Instruments, Inc. — Product Code IDO

K812157 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "LKB-BROMMA 2218 HISTORANGE MICROTOME". The FDA issued a decision of Substantially Equivalent on August 18, 1981. 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
August 18, 1981
Date Received
July 29, 1981
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