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FDA 510(k)

DTR ANALYZER

K-Number: K882913 · 1988-08-30

ApplicantAbbott Laboratories
Decision Date1988-08-30
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DTR ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K882913. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTR ANALYZER?

DTR ANALYZER is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Abbott Laboratories. The 510(k) number is K882913.

When did DTR ANALYZER receive FDA 510(k) clearance?

DTR ANALYZER received FDA 510(k) clearance on 1988-08-30, under 510(k) number K882913.

Who is the listed applicant for DTR ANALYZER?

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

What is the FDA product code for DTR ANALYZER?

The FDA product code for DTR ANALYZER is JJE.

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Related Devices (Code: JJE)

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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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