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FDA 510(k)

AMES TDA GENTAMICIN TEST

K-Number: K821669 · 1982-12-15

ApplicantMiles Laboratories, Inc.
Decision Date1982-12-15
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA GENTAMICIN 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 1982-12-15 under 510(k) number K821669. The device is classified under product code DJB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA GENTAMICIN TEST?

AMES TDA GENTAMICIN TEST is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K821669.

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

AMES TDA GENTAMICIN TEST received FDA 510(k) clearance on 1982-12-15, under 510(k) number K821669.

Who is the listed applicant for AMES TDA GENTAMICIN 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 GENTAMICIN TEST?

The FDA product code for AMES TDA GENTAMICIN TEST is DJB.

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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: DJB)

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.

K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.K831210GENTAMICIN TEST PACK-ACAE.I. Dupont DE Nemours & Co., Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K800537GAMMA STICK GENTAMICIN RIA KITAlpha Gamma LaboratoryK791770QUANTIMUNE GENTAMICIN RIA GENTAMICINBio-Rad

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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