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FDA 510(k)

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR

K-Number: K935794 · 1994-01-25

ApplicantMicrogenics Corp.
Decision Date1994-01-25
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K935794. 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 CEDIA DAU 4-DRUG CUTOFF CALIBRATOR?

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Microgenics Corp.. The 510(k) number is K935794.

When did CEDIA DAU 4-DRUG CUTOFF CALIBRATOR receive FDA 510(k) clearance?

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR received FDA 510(k) clearance on 1994-01-25, under 510(k) number K935794.

Who is the listed applicant for CEDIA DAU 4-DRUG CUTOFF CALIBRATOR?

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 CEDIA DAU 4-DRUG CUTOFF CALIBRATOR?

The FDA product code for CEDIA DAU 4-DRUG CUTOFF CALIBRATOR 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.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.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.

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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