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FDA 510(k)

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM

K-Number: K972406 · 1997-12-22

ApplicantImmunoprobe, Inc.
Decision Date1997-12-22
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunoprobe, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K972406. The device is classified under product code GOD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM?

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Immunoprobe, Inc.. The 510(k) number is K972406.

When did ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM receive FDA 510(k) clearance?

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-12-22, under 510(k) number K972406.

Who is the listed applicant for ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM?

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

What is the FDA product code for ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM?

The FDA product code for ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM is GOD.

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Other records listing Immunoprobe, Inc. 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.

K971393MYCOPLASMA IGG ELISA TEST SYSTEMK961764PR-3 ELISA TEST SYSTEMK961765MPO ELISA TEST SYSTEMK951549EBNA IGG EIA TEST SYSTEMK952523CARDIOLIPIN IGG EIA TEST KITK952522CARDIOLIPIN IGA EIA TEST SYSTEM

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Related Devices (Code: GOD)

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.

K110722RPS ADENO DETECTOR PLUSRapid Pathogen Screening, Inc.K052092RPS ADENO DETECTORRapid Pathogen ScreeningK990630SAS ADENO TESTSa Scientific, Inc.K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.K873312ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.

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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