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)

TOXO-CUBE

K-Number: K903968 · 1990-12-18

ApplicantDifco Laboratories, Inc.
Decision Date1990-12-18
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXO-CUBE 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 1990-12-18 under 510(k) number K903968. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXO-CUBE?

TOXO-CUBE is a medical device that received FDA 510(k) clearance on 1990-12-18. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K903968.

When did TOXO-CUBE receive FDA 510(k) clearance?

TOXO-CUBE received FDA 510(k) clearance on 1990-12-18, under 510(k) number K903968.

Who is the listed applicant for TOXO-CUBE?

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 TOXO-CUBE?

The FDA product code for TOXO-CUBE is LGD.

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.

K971120DISPENS-O-DISC (TM) LEVOFLOXACINK971211DISPENS-O-DISC SPARFLOXACINK963508DISPENS-O-DISC MEROPENEMK961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)K954783DRYSLIDE CARTARRHALISK954784DRYSIDE NEISSERIA

View all 121 devices →

Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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.

↑