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FDA 510(k)

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

K-Number: K963116 · 1996-08-20

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-08-20
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1996-08-20 under 510(k) number K963116. 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 UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY?

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K963116.

When did UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY receive FDA 510(k) clearance?

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY received FDA 510(k) clearance on 1996-08-20, under 510(k) number K963116.

Who is the listed applicant for UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY?

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

What is the FDA product code for UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY?

The FDA product code for UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY is JMO.

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Other records listing Diagnostic Chemicals , Ltd. 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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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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