510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K812158Substantially Equivalent

Lkb-Bromma 2188 Ultrotome Nova

Lkb Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812158 is the FDA 510(k) clearance record for LKB-BROMMA 2188 ULTROTOME NOVA, a class I device, cleared for Lkb Instruments, Inc. on under FDA product code IDM (Microtome, Ultra). FDA records list 52 510(k) clearances for Lkb Instruments, Inc., from to . As of , FDA records show no recalls naming K812158.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IDM Microtome, Ultra
Regulation
21 CFR 864.3010
Device class
Class I
Review panel
Pathology
Applicant
Lkb Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IDM

Trailing 12 months

FDA records hold no clearances under product code IDM in the trailing twelve months.

FDA records show no clearances under product code IDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IDM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260