FDA 510(k)

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR

K-Number: K093492 · 2010-03-19

Decision Date2010-03-19

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR 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 2010-03-19 under 510(k) number K093492. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR?

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR is a medical device that received FDA 510(k) clearance on 2010-03-19. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K093492.

When did MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR receive FDA 510(k) clearance?

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR received FDA 510(k) clearance on 2010-03-19, under 510(k) number K093492.

Who is the listed applicant for MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR?

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 CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR?

The FDA product code for MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR is JJY.

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Official Source

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