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FDA 510(k)

DIRECT

K-Number: K852960 · 1986-06-16

ApplicantUniversity of Wisconsin
Decision Date1986-06-16
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is University of Wisconsin. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K852960. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT?

DIRECT is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is University of Wisconsin. The 510(k) number is K852960.

When did DIRECT receive FDA 510(k) clearance?

DIRECT received FDA 510(k) clearance on 1986-06-16, under 510(k) number K852960.

Who is the listed applicant for DIRECT?

The FDA 510(k) record lists University of Wisconsin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT?

The FDA product code for DIRECT is CGA.

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Related PubMed Literature

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.

PMID: 41450770Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?Journal of law and the biosciences ()PMID: 40833550Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions.Drug safety ()PMID: 34857221Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings.Clinical nutrition ESPEN ()PMID: 27774217A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States.Journal of law and the biosciences ()

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.

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