510(k) Report

FDA product code · Clinical chemistry

Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes

CJHClass II21 CFR 862.1050510(k) required1 decision since 19800 recalls

1 FDA decision since 1980. 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 CJH 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 · CJH

FDA has decided no CJH device since 2007.

Median 510(k) review, days · CJH

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

Recalls per year · CJH

No recall names CJH since 2007.

Adverse event reports per year · CJH

No MAUDE report names CJH 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 — CJH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.1050.