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510(k) K844075

URIC ACID REAGENT SET by Livonia Diagnostics, Inc. — Product Code LFQ

K844075 is an FDA 510(k) premarket notification submitted by Livonia Diagnostics, Inc. for the device "URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code LFQ (Acid, Uric, Acid Reduction Of Ferric Ion), a Class I device regulated under 21 CFR 862.1775. Livonia Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
October 19, 1984
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 Livonia Diagnostics, Inc.

  • K852161 — SERUM IRON/VIBC REAGENT SET (June 10, 1985)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K844182 — INORGANIC PHOSPHORUS REAGENT SET (November 9, 1984)
  • K843894 — HDL PRECIPATATING REAGENT SET (November 2, 1984)
  • K843895 — TOTAL CALCIUM REAGENT SET (October 30, 1984)
  • K843893 — MAGNESIUM REAGENT SET (October 30, 1984)
  • K844024 — CREATININE REAGENT SET (October 30, 1984)

Other clearances for product code LFQ

  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K860142 — URIC ACID REAGENT SET (COLORIMETRIC) (February 11, 1986)
  • K812313 — SANDARE URIC ACID PROCEDURE (September 1, 1981)
  • K811764 — URIC ACID REAGENT SET (August 20, 1981)

FDA data resources