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FDA 510(k)

CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST

K-Number: K883321 · 1988-10-25

ApplicantHeraeus Kulzer, Inc.
Decision Date1988-10-25
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883321. 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 CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST?

CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K883321.

When did CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST receive FDA 510(k) clearance?

CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883321.

Who is the listed applicant for CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST?

The FDA product code for CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST is JJE.

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Related Devices (Code: JJE)

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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