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510(k) K780886

SYSTEM 6000 AUTOMATED RIA ANALYZER by Beckman Instruments, Inc. — Product Code LCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1978
Date Received
May 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Radioimmunoassay Systems, For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Beckman Instruments, Inc.

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  • 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 LCI

  • K983617 — 25-HYDROXYVITAMIN D 125I RIA KIT (November 16, 1998)
  • K801037 — CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (May 28, 1980)