Home / 510(k) Clearances / K992847

510(k) K992847

HICHEM BUN REAGENT by Elan Holdings, Inc. — Product Code LFP

K992847 is an FDA 510(k) premarket notification submitted by Elan Holdings, Inc. for the device "HICHEM BUN REAGENT". The FDA issued a decision of Substantially Equivalent on October 14, 1999. The device falls under product code LFP (Conductivity Rate, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Elan Holdings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1999
Date Received
August 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conductivity Rate, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Elan Holdings, Inc.

  • K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (November 9, 2001)
  • K012474 — ATAC PAK CPK REAGENT KIT (October 3, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)
  • K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (May 24, 2000)
  • K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (May 2, 2000)
  • K992842 — HICHEM ISE ELECTROLYTE REFERENCE (November 26, 1999)
  • K992844 — HICHEM ISE ELECTROLYTE BUFFER (November 26, 1999)
  • K992845 — HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIB (October 18, 1999)
  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)

Other clearances for product code LFP

  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K963537 — SIGMA DIAGNOSTICS BUN REAGENT (October 24, 1996)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K812945 — LIQUILYME BUN REAGENT (November 6, 1981)

FDA data resources