EZ DETECH-URINE BLOOD TEST STICKS— 510(k) K854358

Name: FDA 510(k) clearance K854358
Creator: U.S. Food and Drug Administration
Published: 1986-04-09

Substantially Equivalent

Self Care Systems, Inc.

FDA 510(k) clearance K854358 for EZ DETECH-URINE BLOOD TEST STICKS, Substantially Equivalent on 1986-04-09. Applicant: Self Care Systems, Inc.. Device class: 2.

Clearance details

Applicant: Self Care Systems, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1985-10-29
Decision date: 1986-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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K860923 — EZ DETECT, 5 MINUTE STREP-A COLOR TEST1986-05-16
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Data sourced from openFDA. This site is unofficial and independent of the FDA.