BILIRUBIN RAPID STAT KIT— 510(k) K780826

Substantially Equivalent

Pierce Chemical Co.

FDA 510(k) clearance K780826 for BILIRUBIN RAPID STAT KIT, Substantially Equivalent on 1978-05-26. Applicant: Pierce Chemical Co.. Device class: 2.

Clearance details

Applicant: Pierce Chemical Co.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1978-05-19
Decision date: 1978-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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