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FDA 510(k)

AMES RIALYZE - CHROMATOGRAPHY TUBES

K-Number: K800169 · 1980-02-13

ApplicantMiles Laboratories, Inc.
Decision Date1980-02-13
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES RIALYZE - CHROMATOGRAPHY TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800169. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES RIALYZE - CHROMATOGRAPHY TUBES?

AMES RIALYZE - CHROMATOGRAPHY TUBES is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800169.

When did AMES RIALYZE - CHROMATOGRAPHY TUBES receive FDA 510(k) clearance?

AMES RIALYZE - CHROMATOGRAPHY TUBES received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800169.

Who is the listed applicant for AMES RIALYZE - CHROMATOGRAPHY TUBES?

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

What is the FDA product code for AMES RIALYZE - CHROMATOGRAPHY TUBES?

The FDA product code for AMES RIALYZE - CHROMATOGRAPHY TUBES is CDX.

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Related Devices (Code: CDX)

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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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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