Home / 510(k) Clearances / K982680

510(k) K982680

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY by Chiron Diagnostics Corp. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1998
Date Received
July 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Chiron Diagnostics Corp.

  • K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (August 5, 1999)
  • K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE (June 30, 1999)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • K981478 — ACS:CENTAUR CEA (August 12, 1998)
  • K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY (August 12, 1998)
  • K981592 — ACS:CENTAUR AFP (July 7, 1998)
  • K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (March 3, 1998)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K974325 — CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (December 8, 1997)
  • K970695 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER AN (August 8, 1997)

Other clearances for product code MOI

  • K240403 — Access BR Monitor (May 9, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K193489 — ADVIA Centaur BR (February 13, 2020)
  • K192777 — ADVIA Centaur CA 15-3 assay (November 22, 2019)
  • K181492 — Elecsys CA 15-3 II (June 22, 2018)
  • K171605 — Elecsys CA 15-3 II (February 20, 2018)
  • K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALI (April 18, 2011)
  • K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 3876 (October 26, 2007)
  • K042732 — ARCHITECT CA 15-3 ASSAY (December 22, 2004)