Home / 510(k) Clearances / K800304

510(k) K800304

CENTRIFICHEM FILTER CALIBRATION SET by Union Carbide Corp. — Product Code JIW

K800304 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CENTRIFICHEM FILTER CALIBRATION SET". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
February 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
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 JIW

  • K973055 — WAKO CH50 LINEARITY SET (September 25, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT (April 3, 1991)
  • K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (October 4, 1990)
  • K902294 — ACCUSCAN MICROBEAD STANDARDS (July 3, 1990)
  • K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (June 21, 1989)
  • K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (December 14, 1988)
  • K882220 — CALIBRATION KIT (August 2, 1988)
  • K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (June 7, 1988)
  • K880610 — UNIMETER CALIBRATION KIT (March 24, 1988)

FDA data resources