ROSYS MODELS 100 AND 200— 510(k) K913664

Name: FDA 510(k) clearance K913664
Creator: U.S. Food and Drug Administration
Published: 1991-08-30

Substantially Equivalent

Packard Instrument Co., Inc.

FDA 510(k) clearance K913664 for ROSYS MODELS 100 AND 200, Substantially Equivalent on 1991-08-30. Applicant: Packard Instrument Co., Inc.. Device class: 1.

Clearance details

Applicant: Packard Instrument Co., Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1991-08-16
Decision date: 1991-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downers Grove, IL, US

Download summary PDF View on FDA.gov ↗

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