510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151786Substantially Equivalent

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151786 is the FDA 510(k) clearance record for Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet, a class II device, cleared for Roche Diagnostics on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K151786.

Clearance record

Decision date
Received
(85 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260