Fibri Quik

• • Terminated Z-0053-05 FDA Unclassified (pre-2012) ·initiated 20 Aug 2004

  Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

510(k) Number

K802117 ↗

FDA Product Code

GJA

Device Class

Class II

Regulation

21 CFR Part 864.7875

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Cefazolin 30MCG. Antimicrobial Suscep

  Class II

  FDA 510(k) K831179 Active Cleared 9 May 1983

• Quali. Enzyme Immuno. of Barbiturates in Urine

  Class II

  FDA 510(k) K864993 Active Cleared 31 Mar 1987

• Simplate

  Class II

  FDA 510(k) K761250 Active Cleared 1 Mar 1977

• Chem-Strate Cholesterol

  Class I

  FDA 510(k) K792478 Active Cleared 27 Dec 1979

• Profile Cardiac Set Assayed Serum Contr.

  Class I

  FDA 510(k) K803036 Active Cleared 22 Dec 1980

• Micro-Id

  Class I

  FDA 510(k) K760790 Active Cleared 29 Oct 1976

See all devices from General Diagnostics →