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510(k) K971958

SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT by Beckman Instruments, Inc. — Product Code DDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
May 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

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  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

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  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (March 21, 2007)
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