Home / 510(k) Clearances / K830636

510(k) K830636

POTASSIUM DILUENT by Shaban Mfg. Co. — Product Code JIH

K830636 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "POTASSIUM DILUENT". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code JIH (Flame Photometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
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)
  • 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 JIH

  • K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (March 4, 2005)
  • K031579 — INSTAREAD LITHIUM SYSTEM (December 19, 2003)
  • K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (June 7, 2001)
  • K934106 — KODAK EKTACHEM DTSC II SLIDES (LI) (April 25, 1994)
  • K924488 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (January 26, 1993)
  • K921403 — MODEL 654 ANALYZER (July 30, 1992)
  • K895465 — AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (December 27, 1989)
  • K894328 — TDX(R) LITES(TM) LITHIUM (November 13, 1989)
  • K800039 — LITHIUM DILUENT (1500 MM/E) (January 21, 1980)
  • K771303 — FLAME PHOTOMETER MODEL 460 (August 22, 1977)

FDA data resources