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FDA 510(k)

GENTAMICIN KIT(FPIA)

K-Number: K852013 · 1985-06-10

ApplicantWindsor Laboratories, Inc.
Decision Date1985-06-10
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN KIT(FPIA) is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K852013. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN KIT(FPIA)?

GENTAMICIN KIT(FPIA) is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K852013.

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

GENTAMICIN KIT(FPIA) received FDA 510(k) clearance on 1985-06-10, under 510(k) number K852013.

Who is the listed applicant for GENTAMICIN KIT(FPIA)?

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

What is the FDA product code for GENTAMICIN KIT(FPIA)?

The FDA product code for GENTAMICIN KIT(FPIA) is LCQ.

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Other records listing Windsor 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870389DIGOXIN (FPIA) CALIBRATOR KITK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

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Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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