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FDA 510(k)

AMES TDA N-ACETYL-PROCAINAMIDE TEST

K-Number: K831399 · 1983-06-02

ApplicantMiles Laboratories, Inc.
Decision Date1983-06-02
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA N-ACETYL-PROCAINAMIDE TEST 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 1983-06-02 under 510(k) number K831399. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA N-ACETYL-PROCAINAMIDE TEST?

AMES TDA N-ACETYL-PROCAINAMIDE TEST is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K831399.

When did AMES TDA N-ACETYL-PROCAINAMIDE TEST receive FDA 510(k) clearance?

AMES TDA N-ACETYL-PROCAINAMIDE TEST received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831399.

Who is the listed applicant for AMES TDA N-ACETYL-PROCAINAMIDE TEST?

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 TDA N-ACETYL-PROCAINAMIDE TEST?

The FDA product code for AMES TDA N-ACETYL-PROCAINAMIDE TEST is LAN.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories

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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