510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162840Substantially Equivalent

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

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

K162840 is the FDA 510(k) clearance record for Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5, a class II device, cleared for Roche Diagnostics on under FDA product code MRG (System, Test, Vitamin D). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show 2 recalls naming K162840.

Clearance record

Decision date
Received
(120 days to decision)
Product code
MRG System, Test, Vitamin D
Regulation
21 CFR 862.1825
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 MRG

Trailing 12 months

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

FDA records show no clearances under product code MRG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRG, 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