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510(k) K770530

CLEON IMAGER by Union Carbide Corp. — Product Code JAM

K770530 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CLEON IMAGER". The FDA issued a decision of Substantially Equivalent on April 5, 1977. The device falls under product code JAM (Scanner, Whole Body, Nuclear), a Class I device regulated under 21 CFR 892.1330. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1977
Date Received
March 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Whole Body, Nuclear
Device Class
Class I
Regulation Number
892.1330
Review Panel
RA
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 JAM

  • K842895 — WBA - I.R.I.S. (August 27, 1984)
  • K841996 — MAXICAMERA 400T W/BODY CONTOUR TOMOGRA (July 16, 1984)

FDA data resources