Architect B12

FDA 510(k) K121314 · Abbott Laboratories

Substantially Equivalent

510(k) numberK121314

Submission

Device name
Architect B12
Applicant
Abbott Laboratories
Abbott Park, IL, US
Received
May 2, 2012
Decision date
May 17, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CDD – Radioassay, Vitamin B12
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1810
Specialty
Clinical Chemistry

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Questions and answers

When was Architect B12 cleared by the FDA?

Architect B12 (K121314) received a 510(k) decision of Substantially Equivalent on May 17, 2012, 15 days after the submission was received.

What is the product code of K121314?

The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.