ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)— 510(k) K896545

Name: FDA 510(k) clearance K896545
Creator: U.S. Food and Drug Administration
Published: 1989-12-01

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K896545 for ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), Substantially Equivalent on 1989-12-01. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-11-17
Decision date: 1989-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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