Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CEDIA DAU 5-DRUG CALIBRATORS

K-Number: K935792 · 1994-01-25

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

Device Summary

CEDIA DAU 5-DRUG 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 1994-01-25 under 510(k) number K935792. 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 5-DRUG CALIBRATORS?

CEDIA DAU 5-DRUG CALIBRATORS 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 K935792.

When did CEDIA DAU 5-DRUG CALIBRATORS receive FDA 510(k) clearance?

CEDIA DAU 5-DRUG CALIBRATORS received FDA 510(k) clearance on 1994-01-25, under 510(k) number K935792.

Who is the listed applicant for CEDIA DAU 5-DRUG 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 CEDIA DAU 5-DRUG CALIBRATORS?

The FDA product code for CEDIA DAU 5-DRUG CALIBRATORS is DKB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 106 devices →

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.

↑