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510(k) K810129

CENTRIFICHEM SYSTEM 500 by Union Carbide Corp. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
January 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
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)
  • 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)
  • K802436 — CENTRIFICHEM ALBUMIN (October 31, 1980)

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