BILICHEK NON-INVASIVE BILIRUBIN ANALYZER— 510(k) K994438

Name: FDA 510(k) clearance K994438
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

Spectrx, Inc.

FDA 510(k) clearance K994438 for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER, Substantially Equivalent on 2000-02-04. Applicant: Spectrx, Inc.. Device class: 1.

Clearance details

Applicant: Spectrx, Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 1999-12-30
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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