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FDA 510(k)

SANDARE URIC ACID PROCEDURE

K-Number: K812313 · 1981-09-01

ApplicantSandare Chemical Co., Inc.
Decision Date1981-09-01
Product CodeLFQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANDARE URIC ACID PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812313. The device is classified under product code LFQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE URIC ACID PROCEDURE?

SANDARE URIC ACID PROCEDURE is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K812313.

When did SANDARE URIC ACID PROCEDURE receive FDA 510(k) clearance?

SANDARE URIC ACID PROCEDURE received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812313.

Who is the listed applicant for SANDARE URIC ACID PROCEDURE?

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

What is the FDA product code for SANDARE URIC ACID PROCEDURE?

The FDA product code for SANDARE URIC ACID PROCEDURE is LFQ.

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Other records listing Sandare Chemical Co., Inc. 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK860684SANDARE BCG ALBUMIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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Related Devices (Code: LFQ)

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.

K860111URIC ACID REAGENT SETTechnostics Intl.K860142URIC ACID REAGENT SET (COLORIMETRIC)Sterling Diagnostics, Inc.K844075URIC ACID REAGENT SETLivonia Diagnostics, Inc.K811764URIC ACID REAGENT SETAnco Medical Reagents & Assoc.

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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