510(k) Report

FDA product code · Clinical chemistry

Chromatographic Separation, Cpk Isoenzymes

JHTClass II21 CFR 862.1215510(k) required21 decisions since 19760 recalls

21 FDA decisions since 1976. 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 JHT 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 · JHT

FDA has decided no JHT device since 2007.

Median 510(k) review, days · JHT

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

Recalls per year · JHT

No recall names JHT since 2007.

Adverse event reports per year · JHT

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

Planning a device in JHT? 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 JHT lately?

  • K022409Spectral's Cardiac Status CK-MB Rapid TestSpectral Diagnostics, Inc. · 2002
  • K991299Modification to Cardiac Status CK-MB/Myoglobin Rapid One-Step Test, Lifesign MI CK-MB/Myoglobin, Lifesign…Princeton BioMeditech Corp. · 1999
  • K930359Cardio Rep-Cat. NO. 1400 & CK Isoforms Kit 3305Helena Laboratories · 1993
  • K904866Coulter CK-MB Isoenzyme ReagentCoulter Electronics, Inc. · 1990
  • K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc. · 1990
  • K901450Modified Label for Embria-CK, Quick-MB/Micromi-MBIntl. Immunoassay Laboratories, Inc. · 1990

All 21 JHT decisions →

Related product codes

Other codes under 21 CFR 862.1215.

MMI Immunoassay Method, Troponin SubunitCGS Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesJHX Fluorometric Method, Cpk Or IsoenzymesJHW U.V. Method, Cpk IsoenzymesNJV Test, Albumin Cobalt BindingJHS Differential Rate Kinetic Method, Cpk Or…MYT Biosensor, Immunoassay, Cpk Or IsoenzymesJHY Colorimetric Method, Cpk Or Isoenzymes