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FDA 510(k)

CLINISTAT ALBUMIN REAGENT TEST

K-Number: K896910 · 1990-01-18

Decision Date1990-01-18
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT ALBUMIN REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Diagnostics Div.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K896910. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINISTAT ALBUMIN REAGENT TEST?

CLINISTAT ALBUMIN REAGENT TEST is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Miles Diagnostics Div.. The 510(k) number is K896910.

When did CLINISTAT ALBUMIN REAGENT TEST receive FDA 510(k) clearance?

CLINISTAT ALBUMIN REAGENT TEST received FDA 510(k) clearance on 1990-01-18, under 510(k) number K896910.

Who is the listed applicant for CLINISTAT ALBUMIN REAGENT TEST?

The FDA 510(k) record lists Miles Diagnostics Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINISTAT ALBUMIN REAGENT TEST?

The FDA product code for CLINISTAT ALBUMIN REAGENT TEST is CIX.

Related Clinical Trials

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.

Related Devices (Code: CIX)

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

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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