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FDA 510(k)

ABBOTT A-GENT IRON REAGENT KIT

K-Number: K873120 · 1987-08-25

ApplicantAbbott Laboratories
Decision Date1987-08-25
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT A-GENT IRON REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-08-25 under 510(k) number K873120. 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 ABBOTT A-GENT IRON REAGENT KIT?

ABBOTT A-GENT IRON REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-08-25. The listed applicant is Abbott Laboratories. The 510(k) number is K873120.

When did ABBOTT A-GENT IRON REAGENT KIT receive FDA 510(k) clearance?

ABBOTT A-GENT IRON REAGENT KIT received FDA 510(k) clearance on 1987-08-25, under 510(k) number K873120.

Who is the listed applicant for ABBOTT A-GENT IRON REAGENT KIT?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBOTT A-GENT IRON REAGENT KIT?

The FDA product code for ABBOTT A-GENT IRON REAGENT KIT is CFM.

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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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