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FDA 510(k)

MISSION OLYMPUS AU ISE CALIBRATORS

K-Number: K071039 · 2007-08-08

ApplicantDiamond Diagnostics, Inc.
Decision Date2007-08-08
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MISSION OLYMPUS AU ISE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2007-08-08 under 510(k) number K071039. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISSION OLYMPUS AU ISE CALIBRATORS?

MISSION OLYMPUS AU ISE CALIBRATORS is a medical device that received FDA 510(k) clearance on 2007-08-08. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K071039.

When did MISSION OLYMPUS AU ISE CALIBRATORS receive FDA 510(k) clearance?

MISSION OLYMPUS AU ISE CALIBRATORS received FDA 510(k) clearance on 2007-08-08, under 510(k) number K071039.

Who is the listed applicant for MISSION OLYMPUS AU ISE CALIBRATORS?

The FDA 510(k) record lists Diamond Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISSION OLYMPUS AU ISE CALIBRATORS?

The FDA product code for MISSION OLYMPUS AU ISE CALIBRATORS is JIT.

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Other records listing Diamond Diagnostics, Inc. 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.

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CK121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHK121040SMARTLYTE ELECTROLYTE ANALYZERK121140PROLYTE ELECTROLYTE ANALYZERK120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

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Related Devices (Code: JIT)

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.

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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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