510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884550Substantially Equivalent

Creatine Kinase Mb Enzyme Immunoassay Kit

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884550 is the FDA 510(k) clearance record for CREATINE KINASE MB ENZYME IMMUNOASSAY KIT, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JHY (Colorimetric Method, Cpk Or Isoenzymes). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K884550.

Clearance record

Decision date
Received
(115 days to decision)
Product code
JHY Colorimetric Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code JHY

Trailing 12 months

FDA records hold no clearances under product code JHY in the trailing twelve months.

FDA records show no clearances under product code JHY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JHY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260