510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041596Substantially Equivalent

Architect Stat Ck-Mb Immunoassay

Fisher Diagnostics, Middletown VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041596 is the FDA 510(k) clearance record for ARCHITECT STAT CK-MB IMMUNOASSAY, a class II device, cleared for Fisher Diagnostics on under FDA product code JHX (Fluorometric Method, Cpk Or Isoenzymes). FDA records list 16 510(k) clearances for Fisher Diagnostics, from to . As of , FDA records show no recalls naming K041596.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JHX Fluorometric Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Fisher Diagnostics 8365 Valley Pike, Po Bx 307, Middletown VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JHX

Trailing 12 months

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

FDA records show no clearances under product code JHX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JHX, 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