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510(k) K833535

POTASSIUM SODIUM ANALYSIS PRODUCTS by Shaban Mfg. Co. — Product Code JJO

K833535 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "POTASSIUM SODIUM ANALYSIS PRODUCTS". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
September 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Emission Photometer For Clinical Use
Device Class
Class I
Regulation Number
862.2540
Review Panel
CH
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 JJO

  • K873603 — FINNIGAN MAT INCOS 50 (September 22, 1987)
  • K862148 — OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (September 29, 1986)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K834226 — FLAME PHOTOMETERS (June 22, 1984)
  • K841421 — DAILY WASH SOLUTION 5 (May 11, 1984)
  • K841422 — VOLUME TEST DYE 6 (May 11, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K840044 — SDI PREPAX DILUKIT 29-1000 (March 9, 1984)
  • K832886 — FLAME PHOTOMETER T281-T282-T283 (December 8, 1983)

FDA data resources