510(k) Report

510(k) · Cleared

Cleared

Hydroxybutyrate Dehydrogenase Reagent

K834084510(k) TraditionalCleared Feb 4, 198468-day reviewClass I21 CFR 862.1380

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

Sterling Biochemical, Inc. · JKF Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge

Cleared on Feb 4, 1984 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 4, 1984
Review
68 days
Class
Class I
Product code
JKF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K834084Source: 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.

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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 JKF devices

JKF Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKF

FDA has decided no JKF device since 2007.

Median 510(k) review, days · JKF

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

Recalls per year · JKF

No recall names JKF since 2007.

Adverse event reports per year · JKF

No MAUDE report names JKF 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—

More from Sterling Biochemical, Inc.

15 FDA decisions under this applicant name. See the company

  • K844998Glucose (Hexokinase) Reagent SetSterling Biochemical, Inc. · 1985
  • K844251Alt/GPT Reagent SetSterling Biochemical, Inc. · 1985
  • K843332Alkaline Phosphatase Reagent SetSterling Biochemical, Inc. · 1984
  • K842521Ast/Got Reagent Set UV RateSterling Biochemical, Inc. · 1984
  • K840064Urea Nitrogen Reagent SetSterling Biochemical, Inc. · 1984

Recent decisions in JKF

The JKF category page

  • K861855Hydroxybutyrate Dehydrogenase (HBD) Reagent SetSterling Diagnostics, Inc. · 1986

https://510kreport.com/device/K834084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K834084: Hydroxybutyrate Dehydrogenase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834084

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