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)

STAPHYLOCOCCAL PROTEIN A INSOLUBLE

K-Number: K812181 · 1981-08-25

ApplicantOxoid U.S.A., Inc.
Decision Date1981-08-25
Product CodeLHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPHYLOCOCCAL PROTEIN A INSOLUBLE is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1981-08-25 under 510(k) number K812181. The device is classified under product code LHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPHYLOCOCCAL PROTEIN A INSOLUBLE?

STAPHYLOCOCCAL PROTEIN A INSOLUBLE is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K812181.

When did STAPHYLOCOCCAL PROTEIN A INSOLUBLE receive FDA 510(k) clearance?

STAPHYLOCOCCAL PROTEIN A INSOLUBLE received FDA 510(k) clearance on 1981-08-25, under 510(k) number K812181.

Who is the listed applicant for STAPHYLOCOCCAL PROTEIN A INSOLUBLE?

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

What is the FDA product code for STAPHYLOCOCCAL PROTEIN A INSOLUBLE?

The FDA product code for STAPHYLOCOCCAL PROTEIN A INSOLUBLE is LHJ.

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 Oxoid U.S.A., 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.

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

View all 93 devices →

Related Devices (Code: LHJ)

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.

K940557STAPHYTECT-ODUnipath , Ltd.K842709IMMUSTAPH LATEX AGGLUTINATION KITImmucell 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.

↑