SEALITE SCIENCES AQUALITE FSH— 510(k) K970085

Name: FDA 510(k) clearance K970085
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Sealite Sciences, Inc.

FDA 510(k) clearance K970085 for SEALITE SCIENCES AQUALITE FSH, Substantially Equivalent on 1997-02-14. Applicant: Sealite Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Sealite Sciences, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1997-01-10
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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