Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

K-Number: K881894 · 1988-07-08

ApplicantCambridge Bioscience Corp.
Decision Date1988-07-08
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) 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 1988-07-08 under 510(k) number K881894. 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(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)?

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Cambridge Bioscience Corp.. The 510(k) number is K881894.

When did ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) receive FDA 510(k) clearance?

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881894.

Who is the listed applicant for ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)?

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(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)?

The FDA product code for ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ANTIBODIESK873312ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TESTK873082ADENOCLONE(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.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.K873312ADENOCLONE(TM)-IFA, 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.

↑