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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970956 ↗

FDA Product Code

JJY

Models / Variants

Certain Complete Levels 1, 2, And 3

Cvm Levels 1, 2, 3, 4, And 5

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

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

• Chiron Diagnostics Acs: 180 Carbamazepine Assay

  Class II

  FDA 510(k) K964765 Active Cleared 14 Feb 1997

• Chiron Diagnostics Acs: 180 Folate

  Class II

  FDA 510(k) K991582 Active Cleared 30 Jun 1999

See all devices from Chiron Diagnostics Corp. →