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FDA 510(k)

LYME DISEASE ELISA

K-Number: K880476 · 1988-04-26

ApplicantHillcrest Biologicals
Decision Date1988-04-26
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME DISEASE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1988-04-26 under 510(k) number K880476. 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 LYME DISEASE ELISA?

LYME DISEASE ELISA is a medical device that received FDA 510(k) clearance on 1988-04-26. The listed applicant is Hillcrest Biologicals. The 510(k) number is K880476.

When did LYME DISEASE ELISA receive FDA 510(k) clearance?

LYME DISEASE ELISA received FDA 510(k) clearance on 1988-04-26, under 510(k) number K880476.

Who is the listed applicant for LYME DISEASE ELISA?

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

What is the FDA product code for LYME DISEASE ELISA?

The FDA product code for LYME DISEASE ELISA is LSR.

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Other records listing Hillcrest Biologicals as applicant

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K913618ARBOVIRUS IGM IFA TESTK913617ARBOVIRUS IGG IFA TESTK913906Q FEVER IGG IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

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Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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