BIOSCAN REAGENT STRIPS— 510(k) K940043

Name: FDA 510(k) clearance K940043
Creator: U.S. Food and Drug Administration
Published: 1994-04-12

Substantially Equivalent

Bioscan Instruments, Inc.

FDA 510(k) clearance K940043 for BIOSCAN REAGENT STRIPS, Substantially Equivalent on 1994-04-12. Applicant: Bioscan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Bioscan Instruments, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1994-01-05
Decision date: 1994-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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