Para-Pak Formalin

• • Ongoing Z-0520-2024 FDA Class II ·initiated 19 Oct 2023

  Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

510(k) Number

K792705 ↗

FDA Product Code

IGG

Device Class

Class I

Regulation

21 CFR Part 864.4010

Advisory Committee

Pathology

FDA Decision

SESE Substantially Equivalent

• Blastomyces Dermatitidis Antigen (JWW)

  Class II

  FDA 510(k) K792680 Active Cleared 17 Jan 1980

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

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