FDA 510(k)

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS

K-Number: K951071 · 1995-07-24

Decision Date1995-07-24

Product CodeKRZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Alko Diagnostic Corp.. It received FDA 510(k) clearance on 1995-07-24 under 510(k) number K951071. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS?

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS is a medical device that received FDA 510(k) clearance on 1995-07-24. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K951071.

When did ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS receive FDA 510(k) clearance?

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS received FDA 510(k) clearance on 1995-07-24, under 510(k) number K951071.

Who is the listed applicant for ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS?

The FDA 510(k) record lists Alko Diagnostic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS?

The FDA product code for ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS is KRZ.

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Other records listing Alko Diagnostic Corp. as applicant

K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS K970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS K963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS

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Related Devices (Code: KRZ)

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche Diagnostics K041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, Inc.K893984HGB-CAL SET/MULTIPLER&D Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.