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FDA 510(k)

MRI GENTAMICIN RIA KIT

K-Number: K812394 · 1981-09-08

ApplicantMicroanalytic Research, Inc.
Decision Date1981-09-08
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MRI GENTAMICIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microanalytic Research, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812394. 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 MRI GENTAMICIN RIA KIT?

MRI GENTAMICIN RIA KIT is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Microanalytic Research, Inc.. The 510(k) number is K812394.

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

MRI GENTAMICIN RIA KIT received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812394.

Who is the listed applicant for MRI GENTAMICIN RIA KIT?

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

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

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

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Other records listing Microanalytic Research, 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.

K861097TRYPSIN RIA KITK820741MR1 LUTROPIN RIA KITK820740MR1 FOLLITROPIN RIA KITK813516MRI TOBRAMYCIN RIA KITK810949MRI PROLACTIN RIA KITK802754IMMUNOREACTIVE ESTRIOL RIA KIT

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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.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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