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FDA 510(k)

TRILOGY ANALYZER

K-Number: K070704 · 2007-07-13

ApplicantDrew Scientific, Inc.
Decision Date2007-07-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRILOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Drew Scientific, Inc.. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K070704. 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 TRILOGY ANALYZER?

TRILOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Drew Scientific, Inc.. The 510(k) number is K070704.

When did TRILOGY ANALYZER receive FDA 510(k) clearance?

TRILOGY ANALYZER received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070704.

Who is the listed applicant for TRILOGY ANALYZER?

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

What is the FDA product code for TRILOGY ANALYZER?

The FDA product code for TRILOGY ANALYZER is CGA.

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.

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Other records listing Drew Scientific, 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.

K071562D3 HEMATOLOGY ANALYZER, MODEL D3

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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