Home / 510(k) Clearances / K873132

510(k) K873132

BUN REAGENT KIT by A-Kem, Inc. — Product Code LFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 10, 1987
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 A-Kem, Inc.

  • K884224 — TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (December 15, 1988)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (December 9, 1988)
  • K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873131 — CREATININE REAGENT KIT (October 23, 1987)
  • K873130 — WASH SOLUTION KIT (October 23, 1987)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)

Other clearances for product code LFP

  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K992847 — HICHEM BUN REAGENT (October 14, 1999)
  • K963537 — SIGMA DIAGNOSTICS BUN REAGENT (October 24, 1996)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K812945 — LIQUILYME BUN REAGENT (November 6, 1981)