PCL Inc.

Manufacturer

🇰🇷 South Korea·1 Basic UDI-DI·1 Device

PCLOK II PREP UNIVERSAL

FDA registration

PCL INC.·1 product·🇰🇷 South Korea

PCLOK II

FDA registration

PCL INC.·1 product·🇰🇷 South Korea

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

Device

EU IVDR · Eu Ivd Class A ·PCL Inc.·On the market

125-I LABELED HUMAN LUTEINIZING HORMONE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

B-GCG SYSTEM BY RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RABBIT ANTIBODY TO HUMAN T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THYROXINE (T4) 125I

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HUMAN CHORIONIC GONADOTROPHIN STANDARDS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

1-125 LABELED TRIIODOTHYRONINE(T3)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUTENIZING HORMONES

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

THYROID STIMULATING HORMONE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T3 UPTAKE KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RABBIT ANTIBODY TO DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FOLLICLE STIMULATING HORMONE ANTISERUM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SECOND ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN FOLLICLE STIMULATING HORMONE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

I-125 LABELED DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THYROID STIMULATING HORMONE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry