510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031856Substantially Equivalent

Preciset Tdm I and Preciset Tdm II Calibrators

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

K031856 is the FDA 510(k) clearance record for PRECISET TDM I AND PRECISET TDM II CALIBRATORS, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DKB (Calibrators, Drug Mixture). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show 2 recalls naming K031856.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DKB Calibrators, Drug Mixture
Regulation
21 CFR 862.3200
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DKB

Trailing 12 months

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

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