BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COULTER CARBON DIOXIDE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPECIALTY ASSAYED CONTROL-1

FDA 510(k)

FDA Class 2 ·Hematology

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1

FDA 510(k)

FDA Class 2 ·Hematology

CK-NAC ACTIVATED KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOGLOBIN A1C REAGENT SET

FDA 510(k)

FDA Class 2 ·Hematology

ACID PHOSPHATASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sera

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MSI HEMATOLOGY CONTROL +

FDA 510(k)

FDA Class 2 ·Hematology

Albumin BCG2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOCHRON JR. SIGNATURE +

FDA 510(k)

FDA Class 2 ·Hematology

IMUBIND TPA ELISA, MODEL 860

FDA 510(k)

FDA Class 2 ·Hematology

XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat