HYGEIA GC TEST— 510(k) K881064

Substantially Equivalent

Hygeia Sciences

FDA 510(k) clearance K881064 for HYGEIA GC TEST, Substantially Equivalent on 1988-06-02. Applicant: Hygeia Sciences. Device class: 2.

Clearance details

Applicant: Hygeia Sciences
Product code: Code LIR
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1988-03-14
Decision date: 1988-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, 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.