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FDA 510(k)

DIRECT IRON REAGENT SET

K-Number: K834396 · 1984-02-21

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-02-21
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT IRON REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834396. 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 DIRECT IRON REAGENT SET?

DIRECT IRON REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K834396.

When did DIRECT IRON REAGENT SET receive FDA 510(k) clearance?

DIRECT IRON REAGENT SET received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834396.

Who is the listed applicant for DIRECT IRON REAGENT SET?

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

What is the FDA product code for DIRECT IRON REAGENT SET?

The FDA product code for DIRECT IRON REAGENT SET is CFM.

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Other records listing Seragen Diagnostics, Inc. 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.

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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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