510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030012Substantially Equivalent

Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372

Siemens Healthcare Diagnostics Inc., Chaska MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030012 is the FDA 510(k) clearance record for CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372, a class II device, cleared for Beckman Coulter, Inc. 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 no recalls naming K030012.

Clearance record

Decision date
Received
(15 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
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
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