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FDA 510(k)

DIRECT TIBC KIT

K-Number: K000781 · 2000-05-02

ApplicantReference Diagnostics, Inc.
Decision Date2000-05-02
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT TIBC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reference Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000781. 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 DIRECT TIBC KIT?

DIRECT TIBC KIT is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K000781.

When did DIRECT TIBC KIT receive FDA 510(k) clearance?

DIRECT TIBC KIT received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000781.

Who is the listed applicant for DIRECT TIBC KIT?

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

What is the FDA product code for DIRECT TIBC KIT?

The FDA product code for DIRECT TIBC KIT is JMO.

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Other records listing Reference 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.

K053291FERRITIN CALIBRATOR SET, CATALOG NO. 8203K053211RDI HSFERRITIN KITK052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETK030044EXTENDED RANGE HS CRP KIT, CAT NO:9200K030772RDI EXTENDED RANGE CRP CALIBRATOR SETK021609RDI HS CRP KIT

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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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