OLYMPUS LACTATE, OSR6193— 510(k) K042406

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K042406 for OLYMPUS LACTATE, OSR6193, Substantially Equivalent on 2004-12-03. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant
Olympus America, Inc.
Product code
Code JIT
Device class
Class 2
Regulation
21 CFR 862.1150
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irving, TX, US
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