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510(k) K964695

IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT by Beckman Instruments, Inc. — Product Code DCF

K964695 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT". The FDA issued a decision of Substantially Equivalent on April 29, 1997. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1997
Date Received
November 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

Other clearances by Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, (September 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (July 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 (March 18, 1998)
  • 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)

Other clearances for product code DCF

  • K153560 — Optilite Low Level Albumin Kit (August 25, 2016)
  • K143118 — Human Microalbumin kit for use on SPAPLUS (May 26, 2015)
  • K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator (October 15, 2014)
  • K121045 — HUMAN ALBUMIN CSF KIT (June 19, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101203 — TINA-QUANT ALBUMIN GEN 2 (September 10, 2010)
  • K100853 — COBAS 8000 MODULAR SERIES ANALYZER (September 9, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (April 8, 2009)

FDA data resources