510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080481Substantially Equivalent

Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators

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

K080481 is the FDA 510(k) clearance record for ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code DDR (Myoglobin, Antigen, Antiserum, Control). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K080481.

Clearance record

Decision date
Received
(364 days to decision)
Product code
DDR Myoglobin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5680
Device class
Class II
Review panel
Immunology
Applicant
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DDR

Trailing 12 months

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

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