PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY— 510(k) K770942

Name: FDA 510(k) clearance K770942
Creator: U.S. Food and Drug Administration
Published: 1977-07-21

Substantially Equivalent

Pharmaseal Div., Baxter Healthcare Corp.

FDA 510(k) clearance K770942 for PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY, Substantially Equivalent on 1977-07-21. Applicant: Pharmaseal Div., Baxter Healthcare Corp.. Device class: 2.

Clearance details

Applicant: Pharmaseal Div., Baxter Healthcare Corp.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1977-05-24
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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