Home / 510(k) Clearances / K831295

510(k) K831295

AMYLASE REAGENT #88129 by Hi Chem, Inc. — Product Code KHM

K831295 is an FDA 510(k) premarket notification submitted by Hi Chem, Inc. for the device "AMYLASE REAGENT #88129". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code KHM (Nephelometric, Amylase), a Class II device regulated under 21 CFR 862.1070. Hi Chem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
April 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric, Amylase
Device Class
Class II
Regulation Number
862.1070
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)
  • K861283 — AST REAGENT CARTRIDGE (April 28, 1986)

Other clearances for product code KHM

  • K812699 — AMYLASE (October 6, 1981)
  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENT (June 9, 1980)
  • K790797 — AMYLASE REAGENT SET (July 17, 1979)
  • K770400 — REAGENT, AMYLASE LIPASE (April 26, 1977)

FDA data resources