ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)— 510(k) K893036

Name: FDA 510(k) clearance K893036
Creator: U.S. Food and Drug Administration
Published: 1989-06-02

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K893036 for ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS), Substantially Equivalent on 1989-06-02. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1989-04-24
Decision date: 1989-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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