ELX808 Automated Microplate Readers

• • Terminated Z-0574-05 FDA Unclassified (pre-2012) ·initiated 15 Feb 2005

  The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

510(k) Number

K953710 ↗

FDA Product Code

JJQ

Device Class

Class I

Regulation

21 CFR Part 862.2300

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ida-4 and Ipt-Mc

  Class II

  FDA 510(k) K973609 Active Cleared 18 Dec 1997

• The Bio-Tek Uw-Ii

  Class II

  FDA 510(k) K862932 Active Cleared 25 Sep 1986

• Bio-Tek Ear Oximeter

  Class II

  FDA 510(k) K810363 Active Cleared 27 Feb 1981

• ELX800UV

  Class I

  FDA 510(k) K953572 Active Cleared 19 Oct 1995

• Contourograph M-500

  Unclassified

  FDA 510(k) K800591 Active Cleared 2 Apr 1980

• Automated Eia Microplate Reader EL310

  Class I

  FDA 510(k) K842085 Active Cleared 11 Jun 1984

See all devices from Bio-Tek Instruments, Inc. →