Home / 510(k) Clearances / K800129

510(k) K800129

CENTRIFICHEM CREATININE by Union Carbide Corp. — Product Code CEX

K800129 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CENTRIFICHEM CREATININE". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
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 CEX

  • K872891 — LACTATE DEHYDROGENASE ISOENZYME 1 (September 16, 1987)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K842018 — ISO-SEP SYSTEM (September 28, 1984)
  • K821983 — TITAN GEL LDH ISOENZYME KIT (December 22, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)

FDA data resources