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FDA 510(k)

ANALYTICAL TEST PACK, PRIMIDONE

K-Number: K781957 · 1979-01-10

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1979-01-10
Product CodeDJD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ANALYTICAL TEST PACK, PRIMIDONE is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781957. 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 ANALYTICAL TEST PACK, PRIMIDONE?

ANALYTICAL TEST PACK, PRIMIDONE is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K781957.

When did ANALYTICAL TEST PACK, PRIMIDONE receive FDA 510(k) clearance?

ANALYTICAL TEST PACK, PRIMIDONE received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781957.

Who is the listed applicant for ANALYTICAL TEST PACK, PRIMIDONE?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANALYTICAL TEST PACK, PRIMIDONE?

The FDA product code for ANALYTICAL TEST PACK, PRIMIDONE is DJD.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. 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.K813597TDX PRIMIDONEAbbott Laboratories

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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