ACCUTEX BETA-HCG TEST— 510(k) K926112

Substantially Equivalent

J.S. Medical Assoc.

FDA 510(k) clearance K926112 for ACCUTEX BETA-HCG TEST, Substantially Equivalent on 1993-07-28. Applicant: J.S. Medical Assoc.. Device class: 2.

Clearance details

Applicant: J.S. Medical Assoc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1992-12-03
Decision date: 1993-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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K924247 — ACCUTEX ASO LATEX TEST1992-12-07

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