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FDA 510(k)

RIANEN GENTAMICIN RIA KIT

K-Number: K772425 · 1978-01-05

ApplicantNew England Nuclear
Decision Date1978-01-05
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RIANEN GENTAMICIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1978-01-05 under 510(k) number K772425. 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 RIANEN GENTAMICIN RIA KIT?

RIANEN GENTAMICIN RIA KIT is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is New England Nuclear. The 510(k) number is K772425.

When did RIANEN GENTAMICIN RIA KIT receive FDA 510(k) clearance?

RIANEN GENTAMICIN RIA KIT received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772425.

Who is the listed applicant for RIANEN GENTAMICIN RIA KIT?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIANEN GENTAMICIN RIA KIT?

The FDA product code for RIANEN GENTAMICIN RIA KIT is DJB.

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Other records listing New England Nuclear 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.

K841478RIANEN CYCLIC-AMP RADIOIMMUNOASSAYK840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITK834038RIANEN FOLLICLE STIMULATING HORMONEK833376RIANEN LUTEINIZING HORMONE RIA KITK831345RIANEN PROLACTIN 125I KITK801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTION

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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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