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FDA 510(k)

AMES TDA ETHOSUXIMIDE TEST

K-Number: K823801 · 1983-01-14

ApplicantMiles Laboratories, Inc.
Decision Date1983-01-14
Product CodeDLF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA ETHOSUXIMIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823801. The device is classified under product code DLF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA ETHOSUXIMIDE TEST?

AMES TDA ETHOSUXIMIDE TEST is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K823801.

When did AMES TDA ETHOSUXIMIDE TEST receive FDA 510(k) clearance?

AMES TDA ETHOSUXIMIDE TEST received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823801.

Who is the listed applicant for AMES TDA ETHOSUXIMIDE TEST?

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

What is the FDA product code for AMES TDA ETHOSUXIMIDE TEST?

The FDA product code for AMES TDA ETHOSUXIMIDE TEST is DLF.

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Other records listing Miles Laboratories, Inc. 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.

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Related Devices (Code: DLF)

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.

K881607EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.K850174TDX ETHOSUXIMIDEAbbott LaboratoriesK844204EMIT QST ETHOSUXIMIDE ASSAYSyva Co.K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.K823745ADVANCE EMIT-AED ETHOSUXIMIDESyva Co.K792584ACA ETHOSURIMIDE TEST PACKE.I. Dupont DE Nemours & Co., 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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