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FDA 510(k)

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

K-Number: K962864 · 1996-12-18

ApplicantAlko Diagnostic Corp.
Decision Date1996-12-18
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS 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 1996-12-18 under 510(k) number K962864. 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 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS?

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K962864.

When did THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS receive FDA 510(k) clearance?

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS received FDA 510(k) clearance on 1996-12-18, under 510(k) number K962864.

Who is the listed applicant for THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS?

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 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS?

The FDA product code for THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS is KRZ.

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Other records listing Alko Diagnostic Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSK970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMSK960085ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS

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Related Devices (Code: KRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko 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.

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