Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CORVIS ST

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

KING DIAGNOSTICS UREA NITROGEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

KING SODIUM/POTASSIUM STANDARD MODIFIED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

KING DIAGNOSTICS GLUCOSE (HK) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MONITORX LASERX THEOPHYLLINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Myopia Master

FDA 510(k)

FDA Class 2 ·Ophthalmic

SODIUM AND POTASSIUM BY ION SELECTIVE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

KD 0.02 M CALCIUM CHLORIDE SOLUTION

FDA 510(k)

FDA Class 2 ·Hematology

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

FDA 510(k)

FDA Class 2 ·Microbiology

KING DIAGNOSTICS CHLORIDE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry