OPTICLEAR— 510(k) K842485

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K842485 for OPTICLEAR, Substantially Equivalent on 1984-08-10. Applicant: Gelman Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Gelman Sciences, Inc.
Product code: Code JJN
Device class: Class 1
Regulation: 21 CFR 862.2485
Advisory panel: Clinical Chemistry
Date received: 1984-06-25
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.