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510(k) K933679

SIGMA BUN REAGENT by Sigma Chemical Co. — Product Code LFP

K933679 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIGMA BUN REAGENT". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code LFP (Conductivity Rate, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
July 28, 1993
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)
  • K933702 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 (October 8, 1993)

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)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K812945 — LIQUILYME BUN REAGENT (November 6, 1981)

FDA data resources