Randox Albumin

FDA 510(k) K984494 · Randox Laboratories, Ltd.

Substantially Equivalent

510(k) numberK984494

Submission

Device name
Randox Albumin
Applicant
Randox Laboratories, Ltd.
Crumlin, Co. Antrim, GB
Received
December 17, 1998
Decision date
March 23, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CIX – Bromcresol Green Dye-Binding, Albumin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1035
Specialty
Clinical Chemistry

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Questions and answers

When was Randox Albumin cleared by the FDA?

Randox Albumin (K984494) received a 510(k) decision of Substantially Equivalent on March 23, 1999, 96 days after the submission was received.

What is the product code of K984494?

The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.