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510(k) K980528

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) by Chiron Diagnostics Corp. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1998
Date Received
February 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
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)
  • K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (October 15, 1998)
  • K981478 — ACS:CENTAUR CEA (August 12, 1998)
  • K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY (August 12, 1998)
  • K981592 — ACS:CENTAUR AFP (July 7, 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)

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