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FDA 510(k)

DUPONT ACA VANCOMYCIN (VANC) METHOD

K-Number: K945125 · 1995-03-10

ApplicantThe DU Pont Co.
Decision Date1995-03-10
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA VANCOMYCIN (VANC) METHOD is the device name listed in this FDA 510(k) record. The listed applicant is The DU Pont Co.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K945125. 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 DUPONT ACA VANCOMYCIN (VANC) METHOD?

DUPONT ACA VANCOMYCIN (VANC) METHOD is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is The DU Pont Co.. The 510(k) number is K945125.

When did DUPONT ACA VANCOMYCIN (VANC) METHOD receive FDA 510(k) clearance?

DUPONT ACA VANCOMYCIN (VANC) METHOD received FDA 510(k) clearance on 1995-03-10, under 510(k) number K945125.

Who is the listed applicant for DUPONT ACA VANCOMYCIN (VANC) METHOD?

The FDA 510(k) record lists The DU Pont Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPONT ACA VANCOMYCIN (VANC) METHOD?

The FDA product code for DUPONT ACA VANCOMYCIN (VANC) METHOD is LEH.

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Other records listing The DU Pont Co. 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.

K953477MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGINGK953475CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGINGK952891CRONEX LOW ABSORPTION CASSETTEK943704LIPASE CALIBRATORK900492LABELING CHANGE - VIASPAN(TM) (BELZER UW)K885259ACA THYRONINE UPTAKE (TU E) METHOD

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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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