SERUM IRON DIAGNOSTIC TEST KITS— 510(k) K830104

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K830104 for SERUM IRON DIAGNOSTIC TEST KITS, Substantially Equivalent on 1983-01-28. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1983-01-11
Decision date: 1983-01-28
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.