RESUBMITTED FECATWIN SENSITIVE - FECA-EIA— 510(k) K896474

Name: FDA 510(k) clearance K896474
Creator: U.S. Food and Drug Administration
Published: 1990-01-25

Substantially Equivalent

Labsystems, Inc.

FDA 510(k) clearance K896474 for RESUBMITTED FECATWIN SENSITIVE - FECA-EIA, Substantially Equivalent on 1990-01-25. Applicant: Labsystems, Inc.. Device class: 2.

Clearance details

Applicant: Labsystems, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1989-11-13
Decision date: 1990-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

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