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FDA 510(k)

COBAS-FP REAGENTS FOR VANCOMYCIN

K-Number: K901759 · 1990-05-02

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-05-02
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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 1990-05-02 under 510(k) number K901759. 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 COBAS-FP REAGENTS FOR VANCOMYCIN?

COBAS-FP REAGENTS FOR VANCOMYCIN is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K901759.

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

COBAS-FP REAGENTS FOR VANCOMYCIN received FDA 510(k) clearance on 1990-05-02, under 510(k) number K901759.

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

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

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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.

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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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