Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·F C FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY(TM) VAGINAL POUCH

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

FDA 510(k)

FDA Class 2 ·Cardiovascular

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

FDA 510(k)

FDA Class 2 ·Immunology

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA 400: LIPOPROTEINS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTRA 80

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX ERYTROL

FDA 510(k)

FDA Class 2 ·Hematology

PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO PENTRA 60 AND PENTRA 60C+

FDA 510(k)

FDA Class 2 ·Hematology

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

FDA 510(k)

FDA Class 2 ·Dental

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

FDA 510(k)

FDA Class 2 ·Hematology