LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY— 510(k) K880296

Name: FDA 510(k) clearance K880296
Creator: U.S. Food and Drug Administration
Published: 1988-03-24

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K880296 for LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY, Substantially Equivalent on 1988-03-24. Applicant: London Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1988-01-25
Decision date: 1988-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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