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510(k) K860216

SGOT (AST) REAGENT SET by Sterling Diagnostics, Inc. — Product Code CIQ

K860216 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "SGOT (AST) REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 3, 1986. The device falls under product code CIQ (Diazo, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1986
Date Received
January 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
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 CIQ

  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)
  • K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (January 14, 1986)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K841065 — SGOT REAGENT SET (May 1, 1984)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)

FDA data resources