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FDA 510(k)

SANDARE FAST 340 PHOSPHORUS PROCEDURE

K-Number: K812670 · 1981-10-02

ApplicantSandare Chemical Co., Inc.
Decision Date1981-10-02
Product CodeCED
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANDARE FAST 340 PHOSPHORUS 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 1981-10-02 under 510(k) number K812670. The device is classified under product code CED. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE FAST 340 PHOSPHORUS PROCEDURE?

SANDARE FAST 340 PHOSPHORUS PROCEDURE is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K812670.

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

SANDARE FAST 340 PHOSPHORUS PROCEDURE received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812670.

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

The FDA product code for SANDARE FAST 340 PHOSPHORUS PROCEDURE is CED.

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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: CED)

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.

K894288PHOSPHORUS TEST ITEM NUMBER 65416Em Diagnostic Systems, Inc.K840151EKTACHEM CLINICAL CHEM. SLIDESEastman Kodak CompanyK833710BTC URINE LH ASSAYBtc Diagnostics, Inc.K820832PHOSPHORUS ILAmerican Monitor Corp.K811864SIGMA PROCEDURE 265-UVSigma Chemical Co.K811222INORGANIC PHOSPHORUS REAGENTSConnecticut Diagnostics, Ltd.

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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