HIGHPAK-12

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY