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510(k) K981592

ACS:CENTAUR AFP by Chiron Diagnostics Corp. — Product Code LOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1998
Date Received
May 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Hematology
Device Class
Class II
Regulation Number
866.6010
Review Panel
HE
Submission Type

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  • K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (October 15, 1998)
  • K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY (August 12, 1998)
  • K981478 — ACS:CENTAUR CEA (August 12, 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)
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