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FDA 510(k)

CEDIA(R) CARBAMAZEPINE ASSAY

K-Number: K914857 · 1992-01-15

ApplicantMicrogenics Corp.
Decision Date1992-01-15
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA(R) CARBAMAZEPINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K914857. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA(R) CARBAMAZEPINE ASSAY?

CEDIA(R) CARBAMAZEPINE ASSAY is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Microgenics Corp.. The 510(k) number is K914857.

When did CEDIA(R) CARBAMAZEPINE ASSAY receive FDA 510(k) clearance?

CEDIA(R) CARBAMAZEPINE ASSAY received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914857.

Who is the listed applicant for CEDIA(R) CARBAMAZEPINE ASSAY?

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(R) CARBAMAZEPINE ASSAY?

The FDA product code for CEDIA(R) CARBAMAZEPINE ASSAY is KLT.

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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: KLT)

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.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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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