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FDA 510(k)

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.

K-Number: K895484 · 1989-10-04

ApplicantBaxter Healthcare Corp
Decision Date1989-10-04
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K895484. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.?

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895484.

When did STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. receive FDA 510(k) clearance?

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. received FDA 510(k) clearance on 1989-10-04, under 510(k) number K895484.

Who is the listed applicant for STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.?

The FDA product code for STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. is LCD.

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Related Devices (Code: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.

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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