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FDA 510(k)

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

K-Number: K890281 · 1989-03-15

ApplicantCambridge Bioscience Corp.
Decision Date1989-03-15
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Bioscience Corp.. It received FDA 510(k) clearance on 1989-03-15 under 510(k) number K890281. 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 HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES?

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES is a medical device that received FDA 510(k) clearance on 1989-03-15. The listed applicant is Cambridge Bioscience Corp.. The 510(k) number is K890281.

When did HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES receive FDA 510(k) clearance?

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES received FDA 510(k) clearance on 1989-03-15, under 510(k) number K890281.

Who is the listed applicant for HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES?

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

What is the FDA product code for HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES?

The FDA product code for HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES is LSR.

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Other records listing Cambridge Bioscience Corp. as applicant

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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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