BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS— 510(k) K861255

Name: FDA 510(k) clearance K861255
Creator: U.S. Food and Drug Administration
Published: 1986-10-03

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K861255 for BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS, Substantially Equivalent on 1986-10-03. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1986-04-03
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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