IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR— 510(k) K955797

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K955797 for IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR, Substantially Equivalent on 1996-04-05. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DFT
Advisory panel: Immunology
Date received: 1995-12-22
Decision date: 1996-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

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