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510(k) K860142

URIC ACID REAGENT SET (COLORIMETRIC) by Sterling Diagnostics, Inc. — Product Code LFQ

K860142 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "URIC ACID REAGENT SET (COLORIMETRIC)". The FDA issued a decision of Substantially Equivalent on February 11, 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. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1986
Date Received
January 14, 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 Sterling Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914609 — TRIGLYCERIDES REAGENT SET (November 7, 1991)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)

Other clearances for product code LFQ

  • K860111 — URIC ACID REAGENT SET (February 19, 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