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FDA 510(k)

FIAX TEST KIT FOR LYME DISEASE ANTIBODIES

K-Number: K872247 · 1987-10-15

ApplicantWhittaker Bioproducts, Inc.
Decision Date1987-10-15
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR LYME DISEASE ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1987-10-15 under 510(k) number K872247. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TEST KIT FOR LYME DISEASE ANTIBODIES?

FIAX TEST KIT FOR LYME DISEASE ANTIBODIES is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K872247.

When did FIAX TEST KIT FOR LYME DISEASE ANTIBODIES receive FDA 510(k) clearance?

FIAX TEST KIT FOR LYME DISEASE ANTIBODIES received FDA 510(k) clearance on 1987-10-15, under 510(k) number K872247.

Who is the listed applicant for FIAX TEST KIT FOR LYME DISEASE ANTIBODIES?

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

What is the FDA product code for FIAX TEST KIT FOR LYME DISEASE ANTIBODIES?

The FDA product code for FIAX TEST KIT FOR LYME DISEASE ANTIBODIES is LSR.

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Related Devices (Code: LSR)

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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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