ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT— 510(k) K971458

Name: FDA 510(k) clearance K971458
Creator: U.S. Food and Drug Administration
Published: 1997-09-02

Substantially Equivalent

Diagnostic Specialties

FDA 510(k) clearance K971458 for ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT, Substantially Equivalent on 1997-09-02. Applicant: Diagnostic Specialties. Device class: 1.

Clearance details

Applicant: Diagnostic Specialties
Product code: Code JIQ
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1997-04-22
Decision date: 1997-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Metuchen, NJ, US

Download summary PDF View on FDA.gov ↗

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