510(k) Report

FDA product code · Clinical chemistry

Vanillin Pyruvate, Alt/Sgpt

CKCClass I21 CFR 862.1030510(k) exempt2 decisions since 19780 recalls

FDA lists CKC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1978. 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 CKC 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 · CKC

FDA has decided no CKC device since 2007.

Median 510(k) review, days · CKC

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

Recalls per year · CKC

No recall names CKC since 2007.

Adverse event reports per year · CKC

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

Planning a device in CKC? 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

What has FDA decided in CKC lately?

  • K832791Serayzer Alt/SGPT Reagent StripsMiles Laboratories, Inc. · 1983
  • K780507Serum Glutamic-Pyruvic TransaminaseGamma Enterprises, Inc. · 1978

All 2 CKC decisions →

Related product codes

Other codes under 21 CFR 862.1030.

CKD Hydrazone Colorimetry, Alt/SgptCJJ Diazo, Alt/SgptCKA Nadh Oxidation/Nad Reduction, Alt/Sgpt