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510(k) K860109

ENZYMATIC UREA NITROGEN REAGENT SET by Technostics Intl. — Product Code CDQ

K860109 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "ENZYMATIC UREA NITROGEN REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Technostics Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
January 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET (January 21, 1986)
  • K855195 — DIRECT & TOTAL BILIRUBIN SET (January 14, 1986)
  • K855191 — TOTAL PROTEIN REAGENT SET (January 14, 1986)
  • K855154 — INORGANIC PHOSPHORUS REAGENT SET (January 14, 1986)

Other clearances for product code CDQ

  • K203771 — Urea Nitrogen2 (May 31, 2022)
  • K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER (September 2, 2014)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K073295 — UREA/BUN, SCAL, NORTROL, ABTROL (May 29, 2008)
  • K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (October 12, 2007)
  • K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (March 27, 2006)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K024182 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (March 3, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)

FDA data resources