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FDA 510(k)

AMES TDA DISOPYRAMIDE TEST

K-Number: K832766 · 1983-09-29

ApplicantMiles Laboratories, Inc.
Decision Date1983-09-29
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA DISOPYRAMIDE 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 1983-09-29 under 510(k) number K832766. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA DISOPYRAMIDE TEST?

AMES TDA DISOPYRAMIDE TEST is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K832766.

When did AMES TDA DISOPYRAMIDE TEST receive FDA 510(k) clearance?

AMES TDA DISOPYRAMIDE TEST received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832766.

Who is the listed applicant for AMES TDA DISOPYRAMIDE 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 DISOPYRAMIDE TEST?

The FDA product code for AMES TDA DISOPYRAMIDE TEST is KLT.

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Related Devices (Code: KLT)

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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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