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FDA 510(k)

QUANTITOPE 125-I GENTAMICIN RIA KIT

K-Number: K780323 · 1978-03-17

ApplicantKallestad Laboratories, Inc.
Decision Date1978-03-17
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTITOPE 125-I GENTAMICIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1978-03-17 under 510(k) number K780323. 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 QUANTITOPE 125-I GENTAMICIN RIA KIT?

QUANTITOPE 125-I GENTAMICIN RIA KIT is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K780323.

When did QUANTITOPE 125-I GENTAMICIN RIA KIT receive FDA 510(k) clearance?

QUANTITOPE 125-I GENTAMICIN RIA KIT received FDA 510(k) clearance on 1978-03-17, under 510(k) number K780323.

Who is the listed applicant for QUANTITOPE 125-I GENTAMICIN RIA KIT?

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

What is the FDA product code for QUANTITOPE 125-I GENTAMICIN RIA KIT?

The FDA product code for QUANTITOPE 125-I GENTAMICIN RIA KIT is DJB.

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Other records listing Kallestad 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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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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