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510(k) K841610

COMPONENTS FOR POTASSIUM, SODIUM CHLO by Shaban Mfg. Co. — Product Code JGT

K841610 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "COMPONENTS FOR POTASSIUM, SODIUM CHLO". The FDA issued a decision of Substantially Equivalent on May 25, 1984. The device falls under product code JGT (Flame Photometry, Sodium), a Class II device regulated under 21 CFR 862.1665. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1984
Date Received
April 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Shaban Mfg. Co.

  • K853621 — REPLACEMENT PUMP TUBING (December 5, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK 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)
  • K841609 — COMPONENTS FOR PARTIAL PRESSURE ELEE (May 25, 1984)
  • K840557 — REAGENTS & STANDARDS IL 501 NA/K (April 4, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K840468 — PARTIAL PRESS. ELECTRODE MEASUREMENT (March 30, 1984)

Other clearances for product code JGT

  • K896829 — TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (February 23, 1990)
  • K891574 — LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (June 9, 1989)
  • K840216 — SODIUM/POTASSIUM REAGENT SYS (March 19, 1984)
  • K834248 — PARALLEL FLAME PHOTOMETER & SODIUM (January 30, 1984)
  • K811886 — CESIUM DILUENT 7.5M (July 23, 1981)
  • K801892 — KLINAR REAGENT PAK, #36010 (October 23, 1980)
  • K770774 — LYTETEK SYSTEM (July 11, 1977)

FDA data resources