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FDA 510(k)

ABBOTT IMX HTSH

K-Number: K880086 · 1988-04-05

ApplicantAbbott Laboratories
Decision Date1988-04-05
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX HTSH is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880086. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT IMX HTSH?

ABBOTT IMX HTSH is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Abbott Laboratories. The 510(k) number is K880086.

When did ABBOTT IMX HTSH receive FDA 510(k) clearance?

ABBOTT IMX HTSH received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880086.

Who is the listed applicant for ABBOTT IMX HTSH?

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 IMX HTSH?

The FDA product code for ABBOTT IMX HTSH is JLW.

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Related Devices (Code: JLW)

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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