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510(k) K860111

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

K860111 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code LFQ (Acid, Uric, Acid Reduction Of Ferric Ion), a Class I device regulated under 21 CFR 862.1775. Technostics Intl. has at least 10 other 510(k) clearances on record.

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)
  • 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 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)

FDA data resources