DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO— 510(k) K884901

Name: FDA 510(k) clearance K884901
Creator: U.S. Food and Drug Administration
Published: 1989-02-02

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K884901 for DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO, Substantially Equivalent on 1989-02-02. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1988-11-23
Decision date: 1989-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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