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510(k) K871320

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 by American Research Products Co. — Product Code CDW

K871320 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814". The FDA issued a decision of Substantially Equivalent on April 22, 1987. The device falls under product code CDW (Diacetyl-Monoxime, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1987
Date Received
April 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diacetyl-Monoxime, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by American Research Products Co.

  • K942984 — BUN REAGENT (March 1, 1995)
  • K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN (July 19, 1990)
  • K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (May 31, 1990)
  • K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726 (May 31, 1990)
  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)
  • K901702 — NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (April 25, 1990)
  • K900666 — AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (April 19, 1990)
  • K900667 — AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (April 19, 1990)
  • K900571 — AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (April 16, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)

Other clearances for product code CDW

  • K874532 — BLOOD UREA NITROGEN (January 5, 1988)
  • K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (October 1, 1986)
  • K861775 — TWIN BUN/GLUCOSE (June 27, 1986)
  • K860419 — UREA NITROGEN REAGENT SET (February 11, 1986)
  • K850937 — UREA (June 10, 1985)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K841068 — UREA NITROGEN REAGENT SET (May 1, 1984)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

FDA data resources