510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K004002Substantially Equivalent

Immulite Ck-Mb, Model Lkmb1 (100 Tests), Lkmb5 (500 Tests); Immulite 2000 Ck-Mb, Model L2kmb2 (200 Tests), L2kmb6 (600)

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004002 is the FDA 510(k) clearance record for IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600), a class II device, cleared for Diagnostic Products Corp. on under FDA product code JHX (Fluorometric Method, Cpk Or Isoenzymes). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 2 recalls naming K004002.

Clearance record

Decision date
Received
(50 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
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Summary
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