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510(k) K896845

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT by Reagents Applications, Inc. — Product Code CDL

K896845 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code CDL (Berthelot Indophenol, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
December 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Berthelot Indophenol, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Reagents Applications, Inc.

  • K982056 — RAICHEM CO2 REAGENT (June 24, 1998)
  • K972853 — CHOLESTEROL RAPID LIQUID REAGENT (September 24, 1997)
  • K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (July 30, 1992)
  • K915191 — RAI-TROL ELEVATED LIPIDS CONTROL (December 18, 1991)
  • K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT (September 25, 1991)
  • K911899 — RAICHEM SPIA C4 REAGENT (May 9, 1991)
  • K911900 — RAICHEM SPIA C3 REAGENT (May 9, 1991)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K905085 — RAICHEM GGT REAGENT (December 20, 1990)
  • K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (December 20, 1990)

Other clearances for product code CDL

  • K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (July 25, 1989)
  • K871651 — COLORIMETRIC BUN REAGENT KIT (May 12, 1987)
  • K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD (January 13, 1987)
  • K863889 — UREA NITROGEN TEST (November 24, 1986)
  • K863076 — UREAFAST (September 9, 1986)
  • K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET (February 6, 1986)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K822237 — UREA NITROGEN REAGENT SET (MOD. BERTHEL (August 16, 1982)
  • K810261 — EUROCHIMA UREA NITROGEN (February 10, 1981)
  • K801727 — DATA-ZYME UREA NITROGEN, COLORIMETRIC (September 9, 1980)

FDA data resources