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FDA 510(k)

ARCHITECT IVANCOMYCIN

K-Number: K123947 · 2013-08-29

ApplicantBiokit, S.A.
Decision Date2013-08-29
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARCHITECT IVANCOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K123947. 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 ARCHITECT IVANCOMYCIN?

ARCHITECT IVANCOMYCIN is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Biokit, S.A.. The 510(k) number is K123947.

When did ARCHITECT IVANCOMYCIN receive FDA 510(k) clearance?

ARCHITECT IVANCOMYCIN received FDA 510(k) clearance on 2013-08-29, under 510(k) number K123947.

Who is the listed applicant for ARCHITECT IVANCOMYCIN?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT IVANCOMYCIN?

The FDA product code for ARCHITECT IVANCOMYCIN is LEH.

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Other records listing Biokit, S.A. 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.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsK233606ADVIA Centaur EBV-VCA IgMK233605ADVIA Centaur EBV-EBNA IgGK213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsK214068Quantia IgEK181334ADVIA Centaur Herpes-2 IgG

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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)K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01Biokit, S.A.K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDiagnostic Products Corp.K060586ENZYME IMMUNOASSAY, VANCOMYCINRoche Diagnostics 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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