FETAL BOVINE SERUM IN TRANSFER CONTAINER— 510(k) K853441

Name: FDA 510(k) clearance K853441
Creator: U.S. Food and Drug Administration
Published: 1985-08-26

Substantially Equivalent

Newport Biosystems, Inc.

FDA 510(k) clearance K853441 for FETAL BOVINE SERUM IN TRANSFER CONTAINER, Substantially Equivalent on 1985-08-26. Applicant: Newport Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Newport Biosystems, Inc.
Product code: Code KJA
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1985-08-13
Decision date: 1985-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.