510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121314Substantially Equivalent

Architect B12

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121314 is the FDA 510(k) clearance record for ARCHITECT B12, a class II device, cleared for Abbott Laboratories on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K121314.

Clearance record

Decision date
Received
(15 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories 100 Abbott Park Rd., Abbott Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDD

Trailing 12 months

FDA records hold no clearances under product code CDD in the trailing twelve months.

FDA records show no clearances under product code CDD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260