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)

CYTOCLONE A & B EIA

K-Number: K911958 · 1991-07-30

ApplicantCambridge Biotech Corp.
Decision Date1991-07-30
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOCLONE A & B EIA is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Biotech Corp.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K911958. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOCLONE A & B EIA?

CYTOCLONE A & B EIA is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Cambridge Biotech Corp.. The 510(k) number is K911958.

When did CYTOCLONE A & B EIA receive FDA 510(k) clearance?

CYTOCLONE A & B EIA received FDA 510(k) clearance on 1991-07-30, under 510(k) number K911958.

Who is the listed applicant for CYTOCLONE A & B EIA?

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

What is the FDA product code for CYTOCLONE A & B EIA?

The FDA product code for CYTOCLONE A & B EIA is LLH.

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 Biotech 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.

K971169CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)K971170CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)

Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)

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.

↑