510(k) Report

510(k) · Cleared

Cleared

Endab Cholylglycine Enzyme Immuno. Kit

K803296510(k) TraditionalCleared Jan 16, 198117-day reviewClass II21 CFR 862.1177

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

Immunotech Corp. · KWW Radioimmunoassay, Cholyglycine, Bile Acids

Cleared on Jan 16, 1981 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 16, 1981
Review
17 days
Class
Class II
Product code
KWW
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K803296Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KWW devices

KWW Radioimmunoassay, Cholyglycine, Bile Acids: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWW

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWW

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

Recalls per year · KWW

No recall names KWW since 2007.

Adverse event reports per year · KWW

No MAUDE report names KWW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—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—

More from Immunotech Corp.

37 FDA decisions under this applicant name. See the company

  • K954188Opticlone IGG1 Fitc/IGG2A PE Isotypic ControlImmunotech Corp. · 1995
  • K952789Opticlone CD4FITC/CD8 PE Monoclonal AntibodiesImmunotech Corp. · 1995
  • K950626Opticlone CD3/CD4 Monoclonal AntibodiesImmunotech Corp. · 1995
  • K931228Progesterone Radioimmunoassay KitImmunotech Corp. · 1993
  • K911634Microzyme (TM) Free T4 Enzyme Immunoassay TestImmunotech Corp. · 1991

Recent decisions in KWW

The KWW category page

  • K062503Catachem, Inc., Bile Acids Reagents and/or Bile Acids Test KitCatachem, Inc. · 2007
  • K051714Total Bile Acids Assay, Model DZ042ADiazyme Laboratories · 2005
  • K970120Bile Acids Reagent SetTeco Diagnostics · 1997
  • K872296Bile Acids ReagentSigma Diagnostics, Inc. · 1987
  • K781337Conjugated Bile Acids Ria KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1978

https://510kreport.com/device/K803296 · printed Nov 4, 2026

Cite this page

510(k) Report. “K803296: Endab Cholylglycine Enzyme Immuno. Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K803296

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026