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FDA 510(k)

CHEM 1 UIBC (IRON BINDING CAPACITY TEST)

K-Number: K883104 · 1988-10-25

ApplicantTechnicon Instruments Corp.
Decision Date1988-10-25
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM 1 UIBC (IRON BINDING CAPACITY TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883104. 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 CHEM 1 UIBC (IRON BINDING CAPACITY TEST)?

CHEM 1 UIBC (IRON BINDING CAPACITY TEST) is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K883104.

When did CHEM 1 UIBC (IRON BINDING CAPACITY TEST) receive FDA 510(k) clearance?

CHEM 1 UIBC (IRON BINDING CAPACITY TEST) received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883104.

Who is the listed applicant for CHEM 1 UIBC (IRON BINDING CAPACITY TEST)?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEM 1 UIBC (IRON BINDING CAPACITY TEST)?

The FDA product code for CHEM 1 UIBC (IRON BINDING CAPACITY TEST) is JMO.

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Other records listing Technicon Instruments Corp. as applicant

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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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