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FDA 510(k)

ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST

K-Number: K873312 · 1988-02-24

ApplicantCambridge Bioscience Corp.
Decision Date1988-02-24
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST 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 1988-02-24 under 510(k) number K873312. 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 ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST?

ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Cambridge Bioscience Corp.. The 510(k) number is K873312.

When did ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST receive FDA 510(k) clearance?

ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST received FDA 510(k) clearance on 1988-02-24, under 510(k) number K873312.

Who is the listed applicant for ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST?

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 ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST?

The FDA product code for ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST is GOD.

Related Clinical Trials

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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Other records listing Cambridge Bioscience Corp. 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.

K890281HUMAN LYME EIA FOR THE DETECT OF ANTIBODIESK881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTK852969ROTACLONE ROTAVIRUS DIAGNOSTIC KIT

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.K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMImmunoprobe, Inc.K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.

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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