IRON TEST— 510(k) K881202

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K881202 for IRON TEST, Substantially Equivalent on 1988-04-28. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1988-03-21
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.