FDA 510(k)

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K874438 · 1988-01-21

Decision Date1988-01-21

Product CodeLEH

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-01-21 under 510(k) number K874438. 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 STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1988-01-21. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K874438.

When did STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1988-01-21, under 510(k) number K874438.

Who is the listed applicant for STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY is LEH.

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Related Devices (Code: LEH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.