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FDA 510(k)

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN

K-Number: K953528 · 1995-09-12

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-09-12
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K953528. 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 ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN?

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K953528.

When did ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN receive FDA 510(k) clearance?

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953528.

Who is the listed applicant for ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN?

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

What is the FDA product code for ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN?

The FDA product code for ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN is LEH.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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