BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS— 510(k) K875248

Name: FDA 510(k) clearance K875248
Creator: U.S. Food and Drug Administration
Published: 1988-02-24

Substantially Equivalent

Bioscan Instruments, Inc.

FDA 510(k) clearance K875248 for BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS, Substantially Equivalent on 1988-02-24. Applicant: Bioscan Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Bioscan Instruments, Inc.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 1987-12-22
Decision date: 1988-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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