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510(k) K801892

KLINAR REAGENT PAK, #36010 by Hi Chem, Inc. — Product Code JGT

K801892 is an FDA 510(k) premarket notification submitted by Hi Chem, Inc. for the device "KLINAR REAGENT PAK, #36010". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JGT (Flame Photometry, Sodium), a Class II device regulated under 21 CFR 862.1665. Hi Chem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
August 8, 1980
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 Hi Chem, Inc.

  • K960084 — HICHEM GLUCOSE/HK REAGENT KIT (April 4, 1996)
  • K951818 — HICHEM ALT REAGENT KIT (May 15, 1995)
  • K943684 — HICHEM ENZYME VERIFIER KIT (October 4, 1994)
  • K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (May 13, 1994)
  • K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (July 17, 1990)
  • K863617 — ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (October 24, 1986)
  • K862027 — LDP REAGENT CARTRIDGE (NO. 88216) (June 13, 1986)
  • K861893 — GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) (June 5, 1986)
  • K861879 — CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (May 29, 1986)
  • K861284 — AP REAGENT CARTRIDGE (April 28, 1986)

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)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K840216 — SODIUM/POTASSIUM REAGENT SYS (March 19, 1984)
  • K834248 — PARALLEL FLAME PHOTOMETER & SODIUM (January 30, 1984)
  • K811886 — CESIUM DILUENT 7.5M (July 23, 1981)
  • K770774 — LYTETEK SYSTEM (July 11, 1977)

FDA data resources