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510(k) K781454

LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA by Union Carbide Corp. — Product Code CHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1978
Date Received
August 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Titrimetric With Edta And Indicator, Calcium
Device Class
Class II
Regulation Number
862.1145
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 CHW

  • K192730 — CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (September 9, 2020)
  • K113521 — CALCIUM GEN. 2 (May 8, 2012)