AMERLEX ESH KIT— 510(k) K820754

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K820754 for AMERLEX ESH KIT, Substantially Equivalent on 1982-04-15. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1982-03-19
Decision date: 1982-04-15
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.