FDA 510(k)

SANDARE IRON-BINDING CAPACITY PROCEDURE

K-Number: K851395 · 1985-05-07

Decision Date1985-05-07

Product CodeJMO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SANDARE IRON-BINDING CAPACITY 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 1985-05-07 under 510(k) number K851395. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE IRON-BINDING CAPACITY PROCEDURE?

SANDARE IRON-BINDING CAPACITY PROCEDURE is a medical device that received FDA 510(k) clearance on 1985-05-07. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K851395.

When did SANDARE IRON-BINDING CAPACITY PROCEDURE receive FDA 510(k) clearance?

SANDARE IRON-BINDING CAPACITY PROCEDURE received FDA 510(k) clearance on 1985-05-07, under 510(k) number K851395.

Who is the listed applicant for SANDARE IRON-BINDING CAPACITY 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 IRON-BINDING CAPACITY PROCEDURE?

The FDA product code for SANDARE IRON-BINDING CAPACITY PROCEDURE is JMO.

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Other records listing Sandare Chemical Co., Inc. as applicant

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST K862556SANDARE GLYCOHEMOGLOBIN PROCEDURE K860684SANDARE BCG ALBUMIN PROCEDURE K851394SANDARE IRON PROCEDURE K844498SANDARE ALKALINE PHOSPHATASE PROCEDURE K842516SANDARE ACID PHOSPHATASE PROCEDURE

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Related Devices (Code: JMO)

K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories Saic K012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)Bayer Corp.

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.