ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Test, Barbiturate, Over The Counter

FDA classification

FDA Class 2 ·Test, Barbiturate, Over The Counter

9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD

FDA 510(k)

FDA Class 2 ·General Hospital

9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS

FDA 510(k)

FDA Class 2 ·General Hospital

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

TANDEMHEART FEMORAL VENOUS CANNULA SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

PILLAR PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECG Cable/Leadwires

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

QHRV 1 - HEALTH ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST

FDA 510(k)

FDA Class 2 ·Microbiology

NEISSERIA GONORRHOEAE FLUORO-KIT

FDA 510(k)

FDA Class 2 ·Microbiology