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FDA 510(k)

ARBOVIRUS IGM IFA TEST

K-Number: K913618 · 1992-12-03

ApplicantHillcrest Biologicals
Decision Date1992-12-03
Product CodeGQC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARBOVIRUS IGM IFA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K913618. The device is classified under product code GQC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARBOVIRUS IGM IFA TEST?

ARBOVIRUS IGM IFA TEST is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Hillcrest Biologicals. The 510(k) number is K913618.

When did ARBOVIRUS IGM IFA TEST receive FDA 510(k) clearance?

ARBOVIRUS IGM IFA TEST received FDA 510(k) clearance on 1992-12-03, under 510(k) number K913618.

Who is the listed applicant for ARBOVIRUS IGM IFA TEST?

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 ARBOVIRUS IGM IFA TEST?

The FDA product code for ARBOVIRUS IGM IFA TEST is GQC.

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Other records listing Hillcrest Biologicals as applicant

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.

K913617ARBOVIRUS IGG IFA TESTK922374Q FEVER IGM IFA TESTK913906Q FEVER IGG IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)K884829EBV EARLY ANTIGEN (R+D)

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Related Devices (Code: GQC)

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.

K913617ARBOVIRUS IGG IFA TESTHillcrest Biologicals

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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