510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083260Substantially Equivalent

Elecsys Myoglobin Stat, and Elecsys Myoglobin

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083260 is the FDA 510(k) clearance record for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN, a class II device, cleared for Roche Diagnostics on under FDA product code DDR (Myoglobin, Antigen, Antiserum, Control). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K083260.

Clearance record

Decision date
Received
(345 days to decision)
Product code
DDR Myoglobin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5680
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostics 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
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