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FDA 510(k)

FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES

K-Number: K873708 · 1987-11-25

ApplicantWhittaker Bioproducts, Inc.
Decision Date1987-11-25
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR ENA (RNP/SM) 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 1987-11-25 under 510(k) number K873708. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES?

FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K873708.

When did FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES receive FDA 510(k) clearance?

FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES received FDA 510(k) clearance on 1987-11-25, under 510(k) number K873708.

Who is the listed applicant for FIAX TEST KIT FOR ENA (RNP/SM) 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 ENA (RNP/SM) ANTIBODIES?

The FDA product code for FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES is LLL.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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Related Devices (Code: LLL)

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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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