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)

LA-STAPH IDENTIFICATION SYSTEM

K-Number: K831918 · 1983-06-08

ApplicantImmuno-Mycologics, Inc.
Decision Date1983-06-08
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LA-STAPH IDENTIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Mycologics, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831918. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LA-STAPH IDENTIFICATION SYSTEM?

LA-STAPH IDENTIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K831918.

When did LA-STAPH IDENTIFICATION SYSTEM receive FDA 510(k) clearance?

LA-STAPH IDENTIFICATION SYSTEM received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831918.

Who is the listed applicant for LA-STAPH IDENTIFICATION SYSTEM?

The FDA 510(k) record lists Immuno-Mycologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LA-STAPH IDENTIFICATION SYSTEM?

The FDA product code for LA-STAPH IDENTIFICATION SYSTEM is JWX.

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 Immuno-Mycologics, 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.

K120946ALPHA CRYPTOCOCCAL ANTIGEN EIAK112422CRAG LATERAL FLOW ASSAY (LFA)K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

View all 26 devices →

Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, 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.

↑