Sickle-Stat Hemoglobin S Screen Kit

• • Terminated Z-0470-06 FDA Unclassified (pre-2012) ·initiated 16 Dec 2005

  Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

510(k) Number

K841272 ↗

FDA Product Code

GHM

Device Class

Class II

Regulation

21 CFR Part 864.7825

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Biosign

  Class II

  FDA 510(k) K872867 Active Cleared 6 Jul 1988

• Glyco-Sep/Alc Test Kit for Separat of Hemoglobin

  Class II

  FDA 510(k) K852986 Active Cleared 19 Aug 1985

• Bovie Ultrasonic Surgical Aspirator, Model ME2000

  Unclassified

  FDA 510(k) K880166 Active Cleared 18 Feb 1988

• Electrosurgical Cutting & Coagulation Device/Acces

  Class II

  FDA 510(k) K854231 Active Cleared 2 May 1986

• Disposable Arthroscopy Cannula Set

  Class I

  FDA 510(k) K813000 Active Cleared 22 Jan 1982

• Bovie X-10 Electrosurgical Generator(Unit)

  Class II

  FDA 510(k) K844565 Active Cleared 21 Feb 1985

See all devices from Clinical Technology Corp. →