DDRClass II

Myoglobin, Antigen, Antiserum, Control

21 CFR 866.5680 / Immunology

DDR is the FDA product code for Myoglobin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5680. As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2023-09-18, and 12 recalls.

Classification record

Product code: DDR
Device name: Myoglobin, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5680
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 46
Ingested recalls: 12

Clearances, product code DDR

By decision year

46 clearances under product code DDR with a decision year between 1977 and 2023, 1998 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DDR by decision year
Year	Clearances
1977	1
1978	2
1986	1
1990	4
1992	5
1995	3
1996	1
1997	4
1998	9
1999	3
2000	1
2001	2
2002	1
2003	1
2004	1
2005	1
2006	1
2009	2
2012	1
2013	1
2023	1

Applicants with the most clearances

Product code DDR

Applicants holding the most 510(k) clearances under product code DDR
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	11
Behring Diagnostics, Inc.	3
Baxter Diagnostics, Inc.	2
Boehringer Mannheim Corp.	2
Immuno Diagnostic Center, Inc.	2
Roche Diagnostics GmbH	2
Abbott Medical	1
Bayer Corp.	1
Bio-Rad Laboratories Inc.	1
Chiron Diagnostics Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order