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FDA 510(k)

THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

K-Number: K101752 · 2011-04-08

ApplicantMicrogenics Corp.
Decision Date2011-04-08
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K101752. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS?

THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Microgenics Corp.. The 510(k) number is K101752.

When did THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS receive FDA 510(k) clearance?

THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS received FDA 510(k) clearance on 2011-04-08, under 510(k) number K101752.

Who is the listed applicant for THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS?

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 CEDIA MULTI-DRUG OFT CALIBRATORS?

The FDA product code for THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS is DKB.

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Other records listing Microgenics 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, Inc.K062121DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)Dade Behring, 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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