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)

BREWER GEL FOR CAMPYLOBACTER

K-Number: K881502 · 1988-04-27

ApplicantFairleigh Dickinson Laboratories, Inc.
Decision Date1988-04-27
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BREWER GEL FOR CAMPYLOBACTER is the device name listed in this FDA 510(k) record. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. It received FDA 510(k) clearance on 1988-04-27 under 510(k) number K881502. The device is classified under product code KZJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREWER GEL FOR CAMPYLOBACTER?

BREWER GEL FOR CAMPYLOBACTER is a medical device that received FDA 510(k) clearance on 1988-04-27. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. The 510(k) number is K881502.

When did BREWER GEL FOR CAMPYLOBACTER receive FDA 510(k) clearance?

BREWER GEL FOR CAMPYLOBACTER received FDA 510(k) clearance on 1988-04-27, under 510(k) number K881502.

Who is the listed applicant for BREWER GEL FOR CAMPYLOBACTER?

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

What is the FDA product code for BREWER GEL FOR CAMPYLOBACTER?

The FDA product code for BREWER GEL FOR CAMPYLOBACTER is KZJ.

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 Fairleigh Dickinson Laboratories, 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.

K896032MODIFIED ELISA FOR CHLAMYDIAK895187FDL, INC.'S TRANSPORT SYSTEMK883266FDL ELISA FOR CHLAMYDIAK875362BREWER GEL FOR ANAEROBESK853307DIRECT ELISA FOR HERPES SIMPLEX VIRUSK850251ROTALOK SURGICAL HAND TABLE

View all 7 devices →

Related Devices (Code: KZJ)

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.

K875362BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.K872782BBL(R) GASPAK CO2 POUCH(TM)Bd Becton Dickinson Vacutainer Systems PreanalyticK871709ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)Difco Laboratories, Inc.K871238ANABAGScott Laboratories, Inc.K862123BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEMarion Laboratories, Inc.K853534BBL CAMPY POUCHBd Becton Dickinson Vacutainer Systems Preanalytic

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.

↑