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FDA 510(k)

BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA

K-Number: K852158 · 1985-06-25

ApplicantBioprobe Intl., Inc.
Decision Date1985-06-25
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Bioprobe Intl., Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K852158. 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 BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA?

BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Bioprobe Intl., Inc.. The 510(k) number is K852158.

When did BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA receive FDA 510(k) clearance?

BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852158.

Who is the listed applicant for BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA?

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

What is the FDA product code for BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA?

The FDA product code for BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA is LCQ.

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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

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