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FDA 510(k)

AVL OPTI R ANALYZER

K-Number: K000103 · 2000-03-20

ApplicantAvl Scientific Corp.
Decision Date2000-03-20
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AVL OPTI R 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 2000-03-20 under 510(k) number K000103. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVL OPTI R ANALYZER?

AVL OPTI R ANALYZER is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Avl Scientific Corp.. The 510(k) number is K000103.

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

AVL OPTI R ANALYZER received FDA 510(k) clearance on 2000-03-20, under 510(k) number K000103.

Who is the listed applicant for AVL OPTI R 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 OPTI R ANALYZER?

The FDA product code for AVL OPTI R ANALYZER is CHL.

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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 HC7009K993837AVL OPTI CRITICAL CARE ANALYZERK990092AVL OMNI MODULAR ANALYZERK984299AVL OPTI CRITICAL CARE ANALYZERK974784AVL OPTI CRITICAL CARE ANALYZERK974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL

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Related Devices (Code: CHL)

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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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