CALIBRATION SERUM LEVEL 1 & 2— 510(k) K955489

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K955489 for CALIBRATION SERUM LEVEL 1 & 2, Substantially Equivalent on 1996-06-21. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1995-11-27
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

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