HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY— 510(k) K950354

Name: FDA 510(k) clearance K950354
Creator: U.S. Food and Drug Administration
Published: 1995-07-19

Substantially Equivalent

Ml Strategies, Inc.

FDA 510(k) clearance K950354 for HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY, Substantially Equivalent on 1995-07-19. Applicant: Ml Strategies, Inc.. Device class: 2.

Clearance details

Applicant: Ml Strategies, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1995-01-30
Decision date: 1995-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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