HYPRONOSTICON TM— 510(k) K770603

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K770603 for HYPRONOSTICON TM, Substantially Equivalent on 1977-09-02. Applicant: Organon, Inc.. Device class: 1.

Clearance details

Applicant: Organon, Inc.
Product code: Code JMM
Device class: Class 1
Regulation: 21 CFR 862.1400
Advisory panel: Clinical Chemistry
Date received: 1977-03-30
Decision date: 1977-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.