510(k) Report

FDA product code · Clinical chemistry

Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride

CHKClass II21 CFR 862.1170510(k) required1 decision since 19870 recalls

1 FDA decision since 1987. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of CHK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · CHK

FDA has decided no CHK device since 2007.

Median 510(k) review, days · CHK

Too few CHK 510(k)s in any year since 2007 to give a median.

Recalls per year · CHK

No recall names CHK since 2007.

Adverse event reports per year · CHK

No MAUDE report names CHK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CHK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CHK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in CHK lately?

  • K870214Modified Saltex Reagent StripsMiles Laboratories, Inc. · 1987

The one CHK decision →

Related product codes

Other codes under 21 CFR 862.1170.

CHJ Mercuric Thiocyanate, Colorimetry, ChlorideJFS Coulometric, ChlorideCHG Acid, Phosphoric-Tungstic…CGZ Electrode, Ion-Specific, Chloride