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510(k) K801037

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

K801037 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code LCI (Automated Radioimmunoassay Systems, For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Union Carbide Corp.

  • K830337 — MARK III OXYGEN WALKER SYS-LOW PRESS (March 17, 1983)
  • K820836 — MARK III OXYGEN WALKER SYSTEM (April 15, 1982)
  • K820535 — LASER GAS MIXTURES (March 31, 1982)
  • K812536 — LINDE MARK II (September 23, 1981)
  • K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4 (March 27, 1981)
  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • 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)

FDA data resources