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510(k) K860667

ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET by Sterling Diagnostics, Inc. — Product Code CIT

K860667 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 3, 1986. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, 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
February 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, 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 CIT

  • K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250 (September 20, 2010)
  • K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (December 4, 2008)
  • K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE (March 19, 2008)
  • K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (October 3, 2007)
  • K071211 — COBAS C 111 ANALYZER (July 30, 2007)
  • K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (August 8, 2006)
  • K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
  • K013698 — AST (SGOT) (December 21, 2001)
  • K013145 — WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML (November 27, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)

FDA data resources