Acs Digitoxin

• • Terminated Z-0510-2013 FDA Class II ·initiated 14 Nov 2012

  Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

510(k) Number

K970546 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Acs:centaur Afp

  Class II

  FDA 510(k) K981592 Active Cleared 7 Jul 1998

• Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer

  Class II

  FDA 510(k) K971418 Active Cleared 17 Jul 1997

• Chiron Diagnostics ACS:180TU P

  Class II

  FDA 510(k) K970539 Active Cleared 24 Mar 1997

• Speciality Urine 1, 2

  Class I

  FDA 510(k) K971405 Active Cleared 16 Jun 1997

• Certain Complete Levels 1, 2, and 3; Cvm Levels 1, 2, 3, 4, and 5

  Class I

  FDA 510(k) K970956 Active Cleared 8 Apr 1997

• Chiron Diagnostics Acs: 180 Carbamazepine Assay

  Class II

  FDA 510(k) K964765 Active Cleared 14 Feb 1997

See all devices from Chiron Diagnostics Corp. →