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FDA 510(k)

SERUM IRON & SERUM IRON BINDING CAPACITY

K-Number: K842156 · 1984-08-07

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-08-07
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM IRON & SERUM IRON BINDING CAPACITY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-08-07 under 510(k) number K842156. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM IRON & SERUM IRON BINDING CAPACITY?

SERUM IRON & SERUM IRON BINDING CAPACITY is a medical device that received FDA 510(k) clearance on 1984-08-07. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K842156.

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

SERUM IRON & SERUM IRON BINDING CAPACITY received FDA 510(k) clearance on 1984-08-07, under 510(k) number K842156.

Who is the listed applicant for SERUM IRON & SERUM IRON BINDING CAPACITY?

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

What is the FDA product code for SERUM IRON & SERUM IRON BINDING CAPACITY?

The FDA product code for SERUM IRON & SERUM IRON BINDING CAPACITY is CFM.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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Related Devices (Code: CFM)

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.

K984119WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.K981581IRONAbbott LaboratoriesK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCatachem, Inc.K913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.

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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