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510(k) K801037

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA by Union Carbide Corp. — Product Code LCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
May 2, 1980
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

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  • K812536 — LINDE MARK II (September 23, 1981)
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  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K803216 — CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (January 9, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)

Other clearances for product code LCI

  • K983617 — 25-HYDROXYVITAMIN D 125I RIA KIT (November 16, 1998)
  • K780886 — SYSTEM 6000 AUTOMATED RIA ANALYZER (September 1, 1978)