AST REAGENT (PROCEDURE NUMBER 158)— 510(k) K892844

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K892844 for AST REAGENT (PROCEDURE NUMBER 158), Substantially Equivalent on 1989-06-20. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant
Sigma Chemical Co.
Product code
Code CIT
Device class
Class 2
Regulation
21 CFR 862.1100
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Louis, MO, US
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