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FDA 510(k)

GENTAMICIN FLEX REAGENT CARTRIDGE

K-Number: K962819 · 1996-09-13

ApplicantDade Intl., Inc.
Decision Date1996-09-13
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-09-13 under 510(k) number K962819. 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 GENTAMICIN FLEX REAGENT CARTRIDGE?

GENTAMICIN FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is Dade Intl., Inc.. The 510(k) number is K962819.

When did GENTAMICIN FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

GENTAMICIN FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1996-09-13, under 510(k) number K962819.

Who is the listed applicant for GENTAMICIN FLEX REAGENT CARTRIDGE?

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

What is the FDA product code for GENTAMICIN FLEX REAGENT CARTRIDGE?

The FDA product code for GENTAMICIN FLEX REAGENT CARTRIDGE is LCD.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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