LUPO-TEST REGEANT— 510(k) K922326

Substantially Equivalent

Graoipore , Ltd.

FDA 510(k) clearance K922326 for LUPO-TEST REGEANT, Substantially Equivalent on 1993-04-06. Applicant: Graoipore , Ltd.. Device class: 1.

Clearance details

Applicant: Graoipore , Ltd.
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1992-05-11
Decision date: 1993-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyrmont 2009 Australia, AU

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