HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA— 510(k) K861049

Name: FDA 510(k) clearance K861049
Creator: U.S. Food and Drug Administration
Published: 1986-05-29

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K861049 for HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA, Substantially Equivalent on 1986-05-29. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1986-03-19
Decision date: 1986-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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