FDA 510(k)

IRON BINDING CAPACITY CHEMISTRY

K-Number: K780094 · 1978-02-13

Decision Date1978-02-13

Product CodeJMO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IRON BINDING CAPACITY CHEMISTRY is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K780094. 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 BINDING CAPACITY CHEMISTRY?

IRON BINDING CAPACITY CHEMISTRY is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is Harleco. The 510(k) number is K780094.

When did IRON BINDING CAPACITY CHEMISTRY receive FDA 510(k) clearance?

IRON BINDING CAPACITY CHEMISTRY received FDA 510(k) clearance on 1978-02-13, under 510(k) number K780094.

Who is the listed applicant for IRON BINDING CAPACITY CHEMISTRY?

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

What is the FDA product code for IRON BINDING CAPACITY CHEMISTRY?

The FDA product code for IRON BINDING CAPACITY CHEMISTRY is JMO.

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Other records listing Harleco as applicant

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DH K813044ULTRACHEM ALB, ITEM #64970 K813042ULTRACHEM GLUC-DH SET, ITEM #65048 K813038ULTRACHEM TP, ITEM #64974 K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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.