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FDA 510(k)

AMINOGLYCOSIDE TEST SYSTEM

K-Number: K772116 · 1978-04-28

ApplicantNichols Institute Diagnostics
Decision Date1978-04-28
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMINOGLYCOSIDE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K772116. 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 AMINOGLYCOSIDE TEST SYSTEM?

AMINOGLYCOSIDE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K772116.

When did AMINOGLYCOSIDE TEST SYSTEM receive FDA 510(k) clearance?

AMINOGLYCOSIDE TEST SYSTEM received FDA 510(k) clearance on 1978-04-28, under 510(k) number K772116.

Who is the listed applicant for AMINOGLYCOSIDE TEST SYSTEM?

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

What is the FDA product code for AMINOGLYCOSIDE TEST SYSTEM?

The FDA product code for AMINOGLYCOSIDE TEST SYSTEM is DJB.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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.K821669AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K800537GAMMA STICK GENTAMICIN RIA KITAlpha Gamma Laboratory

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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