SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY— 510(k) K972761

Name: FDA 510(k) clearance K972761
Creator: U.S. Food and Drug Administration
Published: 1997-09-25

Substantially Equivalent

Sealite Sciences, Inc.

FDA 510(k) clearance K972761 for SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY, Substantially Equivalent on 1997-09-25. Applicant: Sealite Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Sealite Sciences, Inc.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1997-07-24
Decision date: 1997-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.