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FDA 510(k)

VANCOMYCIN FLEX REAGENT CARTRIDGE

K-Number: K963267 · 1996-09-13

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

Device Summary

VANCOMYCIN 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 K963267. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANCOMYCIN FLEX REAGENT CARTRIDGE?

VANCOMYCIN 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 K963267.

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

VANCOMYCIN FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1996-09-13, under 510(k) number K963267.

Who is the listed applicant for VANCOMYCIN 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 VANCOMYCIN FLEX REAGENT CARTRIDGE?

The FDA product code for VANCOMYCIN FLEX REAGENT CARTRIDGE is LEH.

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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: LEH)

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.

K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo)K123947ARCHITECT IVANCOMYCINBiokit, S.A.K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01Biokit, S.A.K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDiagnostic Products Corp.

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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