510(k) Report

FDA product code · Clinical chemistry

Tetrabromophenolphthalein, Albumin

CJFClass II21 CFR 862.1035510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 CJF 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 · CJF

FDA has decided no CJF device since 2007.

Median 510(k) review, days · CJF

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

Recalls per year · CJF

No recall names CJF since 2007.

Adverse event reports per year · CJF

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

Planning a device in CJF? 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 CJF lately?

  • K830535Flow-Pac Alkaline Phosphate Reagent SetAmresco, Inc. · 1983

The one CJF decision →

Related product codes

Other codes under 21 CFR 862.1035.

CJZ Acid, Hydroxyazobenzene-Benzoic, AlbuminCJQ Radial Immunodiffusion, AlbuminCJW Bromcresol Purple Dye-Binding, AlbuminCJG Tetrabromo-M-Cresolsulfonphthalein, AlbuminCIX Bromcresol Green Dye-Binding, Albumin