MULTICHEM (R) TOTAL BILIRUBIN— 510(k) K874311

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K874311 for MULTICHEM (R) TOTAL BILIRUBIN, Substantially Equivalent on 1987-11-25. Applicant: Simmler, Inc.. Device class: 2.

Clearance details

Applicant: Simmler, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1987-10-20
Decision date: 1987-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.