EMPATICA S.r.l.

FDA registration

EMPATICA S.r.l.·1 product·🇮🇹 Italy

BINDAZYME CLQ CIC EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

MLA ELECTRA 750 COAGULATION TIMER

FDA 510(k)

FDA Class 2 ·Hematology

'QUEST', 'PELANGI' PATIENT EXAM GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

MyClearALIGN Dental Aligner System

FDA 510(k)

FDA Class 2 ·Dental

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ML8 CORONARY STENT SYSTEMS

LAS-R HUMAN COMPLEMENT CLQ TEST

FDA 510(k)

FDA Class 2 ·Immunology

SODIUM/POTASSIUM 140/5 MEQ/L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM/POTASSIUM (100/100 MEQ/E)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N/A

FDA UDI

HARDY DIAGNOSTICS·00819398027175·McFarland Standard, Latex Equivalent # 1, 8ml f...

N/A

FDA UDI

HARDY DIAGNOSTICS·00819398026963·McFarland Standard, Latex Equivalent # 2, 8ml f...

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·MLI 1000 ND:YAG OP LASER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Sysmex e-CHECK XS

FDA registration

STRECK LLC·2 products·🇺🇸 United States

e-CHECK(XS)

FDA registration

Sysmex America, Inc.·2 products·🇺🇸 United States

e-CHECK(XS)

FDA registration

SYSMEX CORPORATION TECHNO PARK·2 products·🇯🇵 Japan