SEALITE SCIENCES, INC. AQUALITE LH— 510(k) K964925

Name: FDA 510(k) clearance K964925
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Sealite Sciences, Inc.

FDA 510(k) clearance K964925 for SEALITE SCIENCES, INC. AQUALITE LH, Substantially Equivalent on 1997-01-22. Applicant: Sealite Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Sealite Sciences, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1996-12-09
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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