LABOTECH AUTOMATED MICROTITER ANALYZER— 510(k) K922081

Name: FDA 510(k) clearance K922081
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Innovative Medical Systems, Inc.

FDA 510(k) clearance K922081 for LABOTECH AUTOMATED MICROTITER ANALYZER, Substantially Equivalent on 1992-09-02. Applicant: Innovative Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Medical Systems, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1992-05-05
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warren, NJ, US

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