Home / 510(k) Clearances / K823535

510(k) K823535

DILUENT, ZEROING SOLUTION & CO-OX/ISE by Shaban Mfg. Co. — Product Code JKT

K823535 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "DILUENT, ZEROING SOLUTION & CO-OX/ISE". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code JKT (Gas Chromatograph, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
November 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatograph, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

Other clearances by Shaban Mfg. Co.

  • K853621 — REPLACEMENT PUMP TUBING (December 5, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)
  • K844781 — MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB (February 1, 1985)
  • K844235 — CHLORIDE STANDARD (November 20, 1984)
  • K842656 — REPLACEMENT PARTS NOVA ELECTROLYTE ANAL (August 12, 1984)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K841609 — COMPONENTS FOR PARTIAL PRESSURE ELEE (May 25, 1984)
  • K840557 — REAGENTS & STANDARDS IL 501 NA/K (April 4, 1984)
  • K840468 — PARTIAL PRESS. ELECTRODE MEASUREMENT (March 30, 1984)

Other clearances for product code JKT

  • K830843 — BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (April 28, 1983)

FDA data resources