510(k) Report

FDA product code · Clinical chemistry

Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes

CJLClass II21 CFR 862.1050510(k) required1 decision since 19820 recalls

1 FDA decision since 1982. 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 CJL 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 · CJL

FDA has decided no CJL device since 2007.

Median 510(k) review, days · CJL

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

Recalls per year · CJL

No recall names CJL since 2007.

Adverse event reports per year · CJL

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

Planning a device in CJL? 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.