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FDA 510(k)

SANDARE FAST 340 PHOSPHOROUS PROCEDURE

K-Number: K800297 · 1980-03-05

ApplicantSandare Chemical Co., Inc.
Decision Date1980-03-05
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANDARE FAST 340 PHOSPHOROUS 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 1980-03-05 under 510(k) number K800297. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE FAST 340 PHOSPHOROUS PROCEDURE?

SANDARE FAST 340 PHOSPHOROUS PROCEDURE is a medical device that received FDA 510(k) clearance on 1980-03-05. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K800297.

When did SANDARE FAST 340 PHOSPHOROUS PROCEDURE receive FDA 510(k) clearance?

SANDARE FAST 340 PHOSPHOROUS PROCEDURE received FDA 510(k) clearance on 1980-03-05, under 510(k) number K800297.

Who is the listed applicant for SANDARE FAST 340 PHOSPHOROUS 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 FAST 340 PHOSPHOROUS PROCEDURE?

The FDA product code for SANDARE FAST 340 PHOSPHOROUS PROCEDURE is CEO.

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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: CEO)

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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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