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510(k) K951751

HICHEM AST REAGENT KIT by Hichem Diagnostics — Product Code CIT

K951751 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HICHEM AST REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1995
Date Received
April 17, 1995
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 Hichem Diagnostics

  • K981794 — HICHEM CALCIUM REAGENT KIT (July 29, 1998)
  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

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