HEMA-TROL Q-CHECK— 510(k) K952385

Name: FDA 510(k) clearance K952385
Creator: U.S. Food and Drug Administration
Published: 1995-09-25

Substantially Equivalent

Medical Specialties Intl., Inc.

FDA 510(k) clearance K952385 for HEMA-TROL Q-CHECK, Substantially Equivalent on 1995-09-25. Applicant: Medical Specialties Intl., Inc.. Device class: 1.

Clearance details

Applicant: Medical Specialties Intl., Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1995-05-22
Decision date: 1995-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

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