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FDA 510(k)

AMINOGLYCOSIDE TEST SYSTEM

K-Number: K780048 · 1978-01-20

ApplicantNichols Institute Diagnostics
Decision Date1978-01-20
Product CodeDID
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 1978-01-20 under 510(k) number K780048. The device is classified under product code DID. 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 1978-01-20. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K780048.

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

AMINOGLYCOSIDE TEST SYSTEM received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780048.

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 DID.

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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: DID)

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.

K820773EMIT-ST URINE COCAINE METABOLITE ASSAYSyva Co.K802038PHENYTOIN REAGENT TEST KITBeckman Instruments, Inc.K780950BIO-MONITOR TOBRAMYCINMonitor Science Corp.K780182TOBRAMYCIN 125I RIA KITNew England Nuclear

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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