MODIFIED SALTEX REAGENT STRIPS— 510(k) K870214

Name: FDA 510(k) clearance K870214
Creator: U.S. Food and Drug Administration
Published: 1987-06-29

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K870214 for MODIFIED SALTEX REAGENT STRIPS, Substantially Equivalent on 1987-06-29. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CHK
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1987-01-20
Decision date: 1987-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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