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FDA 510(k)

AVL OMNI ANALYZER

K-Number: K972733 · 1997-09-09

ApplicantAvl Scientific Corp.
Decision Date1997-09-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AVL OMNI ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Avl Scientific Corp.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K972733. 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 AVL OMNI ANALYZER?

AVL OMNI ANALYZER is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is Avl Scientific Corp.. The 510(k) number is K972733.

When did AVL OMNI ANALYZER receive FDA 510(k) clearance?

AVL OMNI ANALYZER received FDA 510(k) clearance on 1997-09-09, under 510(k) number K972733.

Who is the listed applicant for AVL OMNI ANALYZER?

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

What is the FDA product code for AVL OMNI ANALYZER?

The FDA product code for AVL OMNI ANALYZER is CGA.

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Other records listing Avl Scientific Corp. 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.

K001632OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009K000103AVL OPTI R ANALYZERK993837AVL OPTI CRITICAL CARE ANALYZERK990092AVL OMNI MODULAR ANALYZERK984299AVL OPTI CRITICAL CARE ANALYZERK974784AVL OPTI CRITICAL CARE ANALYZER

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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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