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510(k) K971958

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

K971958 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT". The FDA issued a decision of Substantially Equivalent on Aug 20, 1997. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 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

Other clearances by Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, (Sep 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (Jul 14, 1998)
  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (Mar 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (Feb 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (Feb 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (Dec 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (Dec 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (Dec 15, 1997)

Other clearances for product code DDG

  • K240987 — Access sTfR (Jul 3, 2024)
  • K190495 — Transferrin (Mar 16, 2020)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (Nov 5, 2018)
  • K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS (Feb 13, 2013)
  • K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 (Aug 11, 2008)
  • K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (Aug 8, 2008)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (Aug 8, 2007)
  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (Apr 23, 2007)
  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (Mar 21, 2007)
  • K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR (Jan 24, 2007)

FDA data resources