XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)

FDA 510(k)

FDA Class 2 ·Neurology

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Research and Diagnostic Systems

FDA UDI

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020315·CBC-5D: 12 x 5mL TriPack (4 each Level 1, 2, 3)

Research and Diagnostic Systems

FDA UDI

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CELL-DYN

FDA UDI

ABBOTT LABORATORIES·00380740020323·CELL-DYN 18 PLUS CONTROL

Advanced Instruments GloCyte® High Level Control Vial (Single)

FDA UDI

ADVANCED INSTRUMENTS, INC.·00816068020191·3 mL vial of High Level Control

Research and Diagnostic Systems

FDA UDI

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020353·CBC-7: 10 x 2mL Dual Pack (5 Low, 5 High)

COULTER 4C-ES

FDA UDI

Beckman Coulter, Inc.·15099590222314·COULTER 4C-ES Plus Cell Control

Alinity

FDA UDI

Abbott GmbH·00380740151270·ALINITY h-series CONTROL 29P

COULTER 4C-ES

FDA UDI

Beckman Coulter, Inc.·15099590222277·COULTER 4C-ES Plus Cell Control

CVA for CellDyn

FDA UDI

STRECK, INC.·00844509001584·Assayed linearity control kits that are used to...

QBC Diagnostics

FDA UDI

DRUCKER DIAGNOSTICS·00858092006543·QBC Extended Range Hematology Controls

Para 12 Plus

FDA UDI

STRECK, INC.·00844509000228·A whole blood hematology control specifically f...

CDS™ 3-PD Hematology Control

FDA UDI

CLINICAL DIAGNOSTIC SOLUTIONS, INC.·00812137010247·For in vitro diagnostic use as a control to mon...

Research and Diagnostic Systems

FDA UDI

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020698·CBC-LINE Kit: 6 x 3mL (6 vials each of the var...

e-CHECK

FDA UDI

SYSMEX CORPORATION·14987562460288·E-Check 4X4.5MLX3 Low/Normal/High

Para 4

FDA UDI

STRECK, INC.·00844509000785·A multi-parameter hematology control for small ...

Research and Diagnostic Systems

FDA UDI

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020209·CBC-3D: 8 x 5mL Dual Pack (4 Low, 4 High)