T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL— 510(k) K852008

Name: FDA 510(k) clearance K852008
Creator: U.S. Food and Drug Administration
Published: 1985-05-30

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K852008 for T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL, Substantially Equivalent on 1985-05-30. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant: Alpkem Corp.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

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