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FDA 510(k)

ABBOTT BREATH ACETONE ANALYZER

K-Number: K875029 · 1988-05-27

ApplicantAbbott Laboratories
Decision Date1988-05-27
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT BREATH ACETONE 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 1988-05-27 under 510(k) number K875029. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT BREATH ACETONE ANALYZER?

ABBOTT BREATH ACETONE ANALYZER is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Abbott Laboratories. The 510(k) number is K875029.

When did ABBOTT BREATH ACETONE ANALYZER receive FDA 510(k) clearance?

ABBOTT BREATH ACETONE ANALYZER received FDA 510(k) clearance on 1988-05-27, under 510(k) number K875029.

Who is the listed applicant for ABBOTT BREATH ACETONE 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 ABBOTT BREATH ACETONE ANALYZER?

The FDA product code for ABBOTT BREATH ACETONE ANALYZER is JIN.

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Related Devices (Code: JIN)

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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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