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

Enzyme Immunoassay, Quinidine

Regulation 862.3320

0510(k)s in 12 months (27 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in LBZ

Company510(k)sRecalls
Syva Co.70
Abbott Laboratories30
Innotron of Oregon, Inc.20
Roche Diagnostic Systems, Inc.20
Siemens Healthcare Diagnostics, Inc.02
American Dade10
American Diagnostic Corp.10
Bayer Corp.10
Beckman Instruments, Inc.10
Clinical Data, Inc.10
DateFirm and productCodeLinked 510(k)
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Open, Classified		 LBZK011605
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Open, Classified		 LBZK922913

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