LKB-BROMMA 2188 ULTROTOME NOVA— 510(k) K812158

Name: FDA 510(k) clearance K812158
Creator: U.S. Food and Drug Administration
Published: 1981-09-16

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K812158 for LKB-BROMMA 2188 ULTROTOME NOVA, Substantially Equivalent on 1981-09-16. Applicant: Lkb Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code IDM
Device class: Class 1
Regulation: 21 CFR 864.3010
Advisory panel: Pathology
Date received: 1981-07-29
Decision date: 1981-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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