ClearanceBrief
Panels › Clinical Toxicology › Product code DOG · Class 2

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol

Regulation 862.3320

0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in DOG

Company510(k)sRecalls
American Dade10
Dade, Baxter Travenol Diagnostics, Inc.10
Diagnostic Corp. of America10
Ortho Diagnostics, Inc.10
Syva Co.10
Decided510(k)Device and applicantCode
Mar 11, 1981K810477DCA DIGOX-SYN RIA TEST
Diagnostic Corp. of America
DOG
Dec 22, 1980K803045IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
American Dade
DOG
Aug 31, 1978K781335DIGOXIN RIA (PEG) KIT
Ortho Diagnostics, Inc.
DOG
Oct 21, 1976K760709EMIT DIGOKIN ASSAY
Syva Co.
DOG
Aug 23, 1976K760416DATA-TOPE SYSTEM DIGOXIN RIA
Dade, Baxter Travenol Diagnostics, Inc.
DOG

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