UNIPAK TOTAL & DIRECT BILIRUBIN— 510(k) K771092

Substantially Equivalent

Harleco

FDA 510(k) clearance K771092 for UNIPAK TOTAL & DIRECT BILIRUBIN, Substantially Equivalent on 1977-07-21. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1977-06-16
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.