Genetic Systems Rsv Immunofluorescence Test Kit

• • Terminated Z-0659-05 FDA Unclassified (pre-2012) ·initiated 25 Jan 2005 ·on shared 510(k) K870176

  New instructions to recommend against using samples with visibly high level of blood.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K870176 ↗

FDA Product Code

LKT

Device Class

Class I

Regulation

21 CFR Part 866.3480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Pneumocystis Carinii Immunofluorescence Test Kit

  Class II

  FDA 510(k) K890768 Active Cleared 21 Mar 1989

• Genetic Systems Rsv Reagent Control Slides

  Class I

  FDA 510(k) K873564 Active Cleared 20 Nov 1987

• Microplate Auto-Washer (Motorized Stage)

  Class I

  FDA 510(k) K873542 Active Cleared 23 Sep 1987

• Legionella Immunofluorescent Antibody Test Kit

  Class II

  FDA 510(k) K852237 Active Cleared 22 Aug 1985

• Genetic Systems Pipettor/Dilutor

  Class I

  FDA 510(k) K891765 Active Cleared 1 May 1989

• Genetic Systems Microplate Washer

  Class I

  FDA 510(k) K891768 Active Cleared 1 May 1989

See all devices from Genetic Systems Corp. →