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FDA 510(k)

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158

K-Number: K092051 · 2009-09-21

ApplicantMicrogenics Corp.
Decision Date2009-09-21
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2009-09-21 under 510(k) number K092051. 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 THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158?

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 is a medical device that received FDA 510(k) clearance on 2009-09-21. The listed applicant is Microgenics Corp.. The 510(k) number is K092051.

When did THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 receive FDA 510(k) clearance?

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 received FDA 510(k) clearance on 2009-09-21, under 510(k) number K092051.

Who is the listed applicant for THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158?

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

What is the FDA product code for THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158?

The FDA product code for THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 is JJY.

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Other records listing Microgenics Corp. as applicant

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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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