ECOLYZER CARBOXIMETER— 510(k) K770209

Substantially Equivalent

Iadec, Inc.

FDA 510(k) clearance K770209 for ECOLYZER CARBOXIMETER, Substantially Equivalent on 1977-03-07. Applicant: Iadec, Inc.. Device class: 2.

Clearance details

Applicant
Iadec, Inc.
Product code
Code GHS
Device class
Class 2
Regulation
21 CFR 864.7425
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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