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FDA 510(k)

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25

K-Number: K961587 · 1996-08-27

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-08-27
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 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 1996-08-27 under 510(k) number K961587. 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 (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25?

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K961587.

When did IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 receive FDA 510(k) clearance?

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 received FDA 510(k) clearance on 1996-08-27, under 510(k) number K961587.

Who is the listed applicant for IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25?

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 IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25?

The FDA product code for IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 is JMO.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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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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