Indirect Fluoro-Kit Hsv

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K830623 ↗

FDA Product Code

GQL

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Varicella Zoster Igg Clin-Elisa Test Kit

  Class II

  FDA 510(k) K900688 Active Cleared 15 May 1990

• Immunop. Antimitochondrial Antibody Kit

  Class II

  FDA 510(k) K800229 Active Cleared 21 Feb 1980

• Epstein-Barr Viral Capsid Antigen Igg #4590

  Class I

  FDA 510(k) K883870 Active Cleared 14 Jul 1989

• Epstein-Barr Virus (Ebna-1) Igg Cata. #4550

  Class I

  FDA 510(k) K883600 Active Cleared 11 May 1989

• Immunop. Antismooth Muscle Antibody Kit

  Class II

  FDA 510(k) K800228 Active Cleared 21 Feb 1980

• Igm Cmv Clin-Elisa(Tm) Test System Number: 5530

  Class II

  FDA 510(k) K872942 Active Cleared 11 Jan 1988

See all devices from Clinical Sciences, Inc. →