WAKO(TM) PRETEST 8A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

WAKO(TM) PRETEST 5A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

WAKO(TM) AUTOKIT GPT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

WAKO(TM) IGG-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

GIT SERUM-FREE MEDIUM FOR CELL CULTURE

FDA 510(k)

FDA Class 1 ·Hematology

WAKO(TM) IGM-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

MAGNESIUM STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) UIBC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BioHorizons Implant Systems Inc.

Manufacturer

🇺🇸 United States·3 Importers

A A, SPU PED ADU, 1149381, Qty10

Device

EU MDR · Eu Md Class 2a ·Respironics Novametrix, LLC·On the market·21 countries

TELO HP AD U 150X160 INSERTO 80X65

Device

EU MDR · Eu Md Class 1 ·PLURITEX SRL·On the market·3 countries

microTargeting™ Digital Display Unit (DDU)

FDA UDI

FHC, INC.·00873263004074·Digital Display Unit forNexDrive with Encoder

DDU-2XXX Series Battery Pack Configuration

FDA UDI

DEFIBTECH, L.L.C.·10815098020390·

DDU-1XX Series Pediatric Pads Configuration

FDA UDI

DEFIBTECH, L.L.C.·10815098020437·

DDU-2XXX Series ECGMA Cable, AAMI

FDA UDI

DEFIBTECH, L.L.C.·00815098020515·

DDU-1XX Series Battery Pack Configuration

FDA UDI

DEFIBTECH, L.L.C.·10815098020376·

DDU-1XX Series Adult Rescue Pads

FDA UDI

DEFIBTECH, L.L.C.·00815098020423·