CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS— 510(k) K896454

Name: FDA 510(k) clearance K896454
Creator: U.S. Food and Drug Administration
Published: 1990-01-11

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K896454 for CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS, Substantially Equivalent on 1990-01-11. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1989-11-09
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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