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FDA 510(k)

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA

K-Number: K900604 · 1990-07-26

ApplicantBiovir Laboratories, Inc.
Decision Date1990-07-26
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA is the device name listed in this FDA 510(k) record. The listed applicant is Biovir Laboratories, Inc.. It received FDA 510(k) clearance on 1990-07-26 under 510(k) number K900604. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA?

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA is a medical device that received FDA 510(k) clearance on 1990-07-26. The listed applicant is Biovir Laboratories, Inc.. The 510(k) number is K900604.

When did DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA receive FDA 510(k) clearance?

DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA received FDA 510(k) clearance on 1990-07-26, under 510(k) number K900604.

Who is the listed applicant for DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA?

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

What is the FDA product code for DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA?

The FDA product code for DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA is KHW.

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Related Devices (Code: KHW)

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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.

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