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)

BACTO STAPHYLOCOCCUS LATEX TEST

K-Number: K843560 · 1984-10-01

ApplicantDifco Laboratories, Inc.
Decision Date1984-10-01
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTO STAPHYLOCOCCUS LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K843560. 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 BACTO STAPHYLOCOCCUS LATEX TEST?

BACTO STAPHYLOCOCCUS LATEX TEST is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K843560.

When did BACTO STAPHYLOCOCCUS LATEX TEST receive FDA 510(k) clearance?

BACTO STAPHYLOCOCCUS LATEX TEST received FDA 510(k) clearance on 1984-10-01, under 510(k) number K843560.

Who is the listed applicant for BACTO STAPHYLOCOCCUS LATEX TEST?

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

What is the FDA product code for BACTO STAPHYLOCOCCUS LATEX TEST?

The FDA product code for BACTO STAPHYLOCOCCUS LATEX TEST 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 Difco 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.

K971211DISPENS-O-DISC SPARFLOXACINK971120DISPENS-O-DISC (TM) LEVOFLOXACINK963508DISPENS-O-DISC MEROPENEMK961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)K954783DRYSLIDE CARTARRHALISK954784DRYSIDE NEISSERIA

View all 121 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.

↑