LUPUS(LE)-LATEX TEST— 510(k) K905531

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K905531 for LUPUS(LE)-LATEX TEST, Substantially Equivalent on 1991-01-25. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LKI
Advisory panel: Microbiology
Date received: 1990-12-10
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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