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FDA 510(k)

CEDIA DAU PPX/METH CALIBRATOR

K-Number: K951153 · 1995-04-21

ApplicantMicrogenics Corp.
Decision Date1995-04-21
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU PPX/METH 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 1995-04-21 under 510(k) number K951153. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA DAU PPX/METH CALIBRATOR?

CEDIA DAU PPX/METH CALIBRATOR is a medical device that received FDA 510(k) clearance on 1995-04-21. The listed applicant is Microgenics Corp.. The 510(k) number is K951153.

When did CEDIA DAU PPX/METH CALIBRATOR receive FDA 510(k) clearance?

CEDIA DAU PPX/METH CALIBRATOR received FDA 510(k) clearance on 1995-04-21, under 510(k) number K951153.

Who is the listed applicant for CEDIA DAU PPX/METH 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 PPX/METH CALIBRATOR?

The FDA product code for CEDIA DAU PPX/METH CALIBRATOR is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)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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