MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

FDA 510(k)

FDA Class 2 ·Physical Medicine

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573

HDSES01

FDA registration

HJY SMART MEDICAL DEVICE CO., LTD.·1 product·🇹🇼 Taiwan

MLDLR, HSR02

FDA registration

HJY SMART MEDICAL DEVICE CO., LTD.·1 product·🇹🇼 Taiwan

HHMD01

FDA registration

HJY SMART MEDICAL DEVICE CO., LTD.·1 product·🇹🇼 Taiwan

Isomedix Operations Inc.

FDA registration

Isomedix Operations Inc.·1 product·🇺🇸 United States

AUX Expansion Screw, AUX Retainers

FDA registration

AMERICAN ANGLE ORTHO, LLC·1 product·🇺🇸 United States

Alinity c Calcium Reagent Kit (LN 07P5720, 07P5730)

FDA registration

ABBOTT LABORATORIES·1 product·🇺🇸 United States

STANBIO LABORATORY

FDA registration

STANBIO LABORATORY·1 product·🇺🇸 United States

Randox Calcium (Ca)

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

RANDOX CALCIUM

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

Ca-Color Arsenazo III AA

FDA registration

WIENER LABORATORIOS S.A.I.C.·1 product·🇦🇷 Argentina

Carolina Liquid Chemistries Corp.

FDA registration

Carolina Liquid Chemistries Corp.·1 product·🇺🇸 United States

OSR60117 CALCIUM ARSENAZO

FDA registration

Beckman Coulter Ireland Inc·1 product·🇮🇪 Ireland

CALCIUM ARSENAZO REAGENT

FDA registration

DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI·1 product·🇹🇷 Türkiye

Calcium Assay

FDA registration

Sekisui Diagnostics P.E.I. Inc.·1 product·🇨🇦 Canada