510(k) Report

FDA product code · Clinical chemistry

Acid, Hydroxyazobenzene-Benzoic, Albumin

CJZClass II21 CFR 862.1035510(k) required0 decisions0 recalls

0 FDA decisions. 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 CJZ 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 · CJZ

FDA has decided no CJZ device since 2007.

Median 510(k) review, days · CJZ

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

Recalls per year · CJZ

No recall names CJZ since 2007.

Adverse event reports per year · CJZ

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code CJZ, not matched to any one device; reports are not rates.

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—01
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 — CJZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CJZ? 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 862.1035.

CJQ Radial Immunodiffusion, AlbuminCJW Bromcresol Purple Dye-Binding, AlbuminCJG Tetrabromo-M-Cresolsulfonphthalein, AlbuminCIX Bromcresol Green Dye-Binding, AlbuminCJF Tetrabromophenolphthalein, Albumin