BILIRUBIN (DIRECT)— 510(k) K881172

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K881172 for BILIRUBIN (DIRECT), Substantially Equivalent on 1988-06-07. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1988-03-18
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Park, MI, US

Download summary PDF View on FDA.gov ↗

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