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FDA 510(k)

IRON/UIBC REAGENT

K-Number: K932517 · 1993-11-09

ApplicantSigma Diagnostics, Inc.
Decision Date1993-11-09
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON/UIBC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-11-09 under 510(k) number K932517. 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 IRON/UIBC REAGENT?

IRON/UIBC REAGENT is a medical device that received FDA 510(k) clearance on 1993-11-09. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K932517.

When did IRON/UIBC REAGENT receive FDA 510(k) clearance?

IRON/UIBC REAGENT received FDA 510(k) clearance on 1993-11-09, under 510(k) number K932517.

Who is the listed applicant for IRON/UIBC REAGENT?

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

What is the FDA product code for IRON/UIBC REAGENT?

The FDA product code for IRON/UIBC REAGENT is JMO.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: JMO)

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.

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 SaicK012340BAYER 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.

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