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FDA 510(k)

ALKP

K-Number: K981806 · 1998-06-22

Decision Date1998-06-22
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-06-22 under 510(k) number K981806. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKP?

ALKP is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is Abbott Laboratories. The 510(k) number is K981806.

When did ALKP receive FDA 510(k) clearance?

ALKP received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981806.

Who is the listed applicant for ALKP?

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 ALKP?

The FDA product code for ALKP is CJE.

Other records listing Abbott Laboratories as applicant

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.

View all 876 devices →

Related Devices (Code: CJE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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