AQUALITE FSH— 510(k) K943437

Substantially Equivalent

Sealite Sciences, Inc.

FDA 510(k) clearance K943437 for AQUALITE FSH, Substantially Equivalent on 1994-12-28. 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: 1994-07-18
Decision date: 1994-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogart, GA, US

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