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FDA 510(k)

ABBOTT CLINICAL CHEMISTRY REAGENT ALP

K-Number: K890521 · 1989-03-24

ApplicantAbbott Laboratories
Decision Date1989-03-24
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT CLINICAL CHEMISTRY REAGENT ALP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-03-24 under 510(k) number K890521. 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 ABBOTT CLINICAL CHEMISTRY REAGENT ALP?

ABBOTT CLINICAL CHEMISTRY REAGENT ALP is a medical device that received FDA 510(k) clearance on 1989-03-24. The listed applicant is Abbott Laboratories. The 510(k) number is K890521.

When did ABBOTT CLINICAL CHEMISTRY REAGENT ALP receive FDA 510(k) clearance?

ABBOTT CLINICAL CHEMISTRY REAGENT ALP received FDA 510(k) clearance on 1989-03-24, under 510(k) number K890521.

Who is the listed applicant for ABBOTT CLINICAL CHEMISTRY REAGENT ALP?

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 CLINICAL CHEMISTRY REAGENT ALP?

The FDA product code for ABBOTT CLINICAL CHEMISTRY REAGENT ALP is CJE.

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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.

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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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