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FDA 510(k)

ELVI SERUM IRON

K-Number: K792406 · 1979-12-07

ApplicantVolu Sol Medical Industries
Decision Date1979-12-07
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELVI SERUM IRON is the device name listed in this FDA 510(k) record. The listed applicant is Volu Sol Medical Industries. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K792406. 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 ELVI SERUM IRON?

ELVI SERUM IRON is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Volu Sol Medical Industries. The 510(k) number is K792406.

When did ELVI SERUM IRON receive FDA 510(k) clearance?

ELVI SERUM IRON received FDA 510(k) clearance on 1979-12-07, under 510(k) number K792406.

Who is the listed applicant for ELVI SERUM IRON?

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

What is the FDA product code for ELVI SERUM IRON?

The FDA product code for ELVI SERUM IRON is CFM.

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Other records listing Volu Sol Medical Industries 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.

K822128VOLU-SOL SINGLE DIFFERENTIAL STAINK822127VOLU-SOL ZENKERS FIXATIVEK822126VOLU-SOL CARNOY FLUIDK822129VOLU-SOL BOVINS FIXATIVEK822036VOLU-SOL DECALCIFERK822035VOLU-SOL GILLS EA

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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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