Scalpel

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780998 ↗

FDA Product Code

GDX

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Hdl-Cholesterol Control Serum

  Class I

  FDA 510(k) K802997 Active Cleared 22 Dec 1980

• Resolve-Hb

  Class II

  FDA 510(k) K840011 Active Cleared 4 Feb 1984

• Sickle Hb Assay

  Class II

  FDA 510(k) K841170 Active Cleared 4 Apr 1984

• Hemocard(Tm) Control

  Class II

  FDA 510(k) K924173 Active Cleared 1 Dec 1992

• Isolab's T4 Test Kit

  Class II

  FDA 510(k) K951014 Active Cleared 18 Oct 1996

• Visible-Chlamydia(Tm) Test System

  Class I

  FDA 510(k) K862638 Active Cleared 26 Aug 1986

See all devices from Isolab, Inc. →