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510(k) K860111

URIC ACID REAGENT SET by Technostics Intl. — Product Code LFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1986
Date Received
January 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Acid Reduction Of Ferric Ion
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860109 — ENZYMATIC UREA NITROGEN REAGENT SET (February 6, 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)
  • K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (January 14, 1986)
  • K855153 — GLUCOSE (UV HEXOKIASE) REAGENT SET (January 14, 1986)
  • K855195 — DIRECT & TOTAL BILIRUBIN SET (January 14, 1986)

Other clearances for product code LFQ

  • K860142 — URIC ACID REAGENT SET (COLORIMETRIC) (February 11, 1986)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K812313 — SANDARE URIC ACID PROCEDURE (September 1, 1981)
  • K811764 — URIC ACID REAGENT SET (August 20, 1981)