SDI PREPAX DILUKIT M.— 510(k) K851320

Name: FDA 510(k) clearance K851320
Creator: U.S. Food and Drug Administration
Published: 1985-07-05

Substantially Equivalent

Scientific Distributors, Inc.

FDA 510(k) clearance K851320 for SDI PREPAX DILUKIT M., Substantially Equivalent on 1985-07-05. Applicant: Scientific Distributors, Inc.. Device class: 1.

Clearance details

Applicant: Scientific Distributors, Inc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1985-04-02
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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K840041 — SDI PREPAX DILUKIT HW1984-03-05
K840038 — PREPAX DILUKIT PLUS1984-02-10
K840042 — SDI PREPAX DILUKIT CA1984-02-10

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