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510(k) K970921

STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) by Alko Diagnostic Corp. — Product Code JIX

K970921 is an FDA 510(k) premarket notification submitted by Alko Diagnostic Corp. for the device "STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)". The FDA issued a decision of Substantially Equivalent on April 8, 1997. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Alko Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1997
Date Received
March 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Alko Diagnostic Corp.

  • K001484 — CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; (June 19, 2000)
  • K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID R (September 1, 1998)
  • K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS (June 16, 1997)
  • K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (December 18, 1996)
  • K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS (October 24, 1996)
  • K960085 — ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS (March 11, 1996)
  • K955154 — CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (December 11, 1995)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K950902 — ALKO TONOMETERED SALINE CONTROL (March 30, 1995)
  • K944922 — ALKO CAL PACKS FOR CORNING 654 ANALYZERS (February 10, 1995)

Other clearances for product code JIX

  • K161140 — VITROS Chemistry Products Calibrator Kit 3 (May 20, 2016)
  • K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (December 18, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F (June 15, 2015)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR (November 26, 2013)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)

FDA data resources