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FDA 510(k)

TDX PRIMIDONE

K-Number: K813597 · 1982-01-22

ApplicantAbbott Laboratories
Decision Date1982-01-22
Product CodeDJD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX PRIMIDONE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813597. The device is classified under product code DJD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX PRIMIDONE?

TDX PRIMIDONE is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Abbott Laboratories. The 510(k) number is K813597.

When did TDX PRIMIDONE receive FDA 510(k) clearance?

TDX PRIMIDONE received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813597.

Who is the listed applicant for TDX PRIMIDONE?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDX PRIMIDONE?

The FDA product code for TDX PRIMIDONE is DJD.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: DJD)

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.

K973582ACE PRIMIDONE REAGENT, AED CALIBRATORSSchiapparelli Biosystems, Inc.K910527EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONESyva Co.K840939EMIT QST PRIMIDONE ASSAYSyva Co.K832798MODIFICA-OF EMIT AED PRIMIDONE ASSAYSyva Co.K820138PRIMIDONE REAGENT TEST KITBeckman Instruments, Inc.K802654AMES TDA PRIMIDONE TESTMiles Laboratories, 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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