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FDA 510(k)

LPIA-FERRITIN ASSAY

K-Number: K924186 · 1992-12-23

ApplicantSeradyn, Inc.
Decision Date1992-12-23
Product CodeDEF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LPIA-FERRITIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K924186. The device is classified under product code DEF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LPIA-FERRITIN ASSAY?

LPIA-FERRITIN ASSAY is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Seradyn, Inc.. The 510(k) number is K924186.

When did LPIA-FERRITIN ASSAY receive FDA 510(k) clearance?

LPIA-FERRITIN ASSAY received FDA 510(k) clearance on 1992-12-23, under 510(k) number K924186.

Who is the listed applicant for LPIA-FERRITIN ASSAY?

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

What is the FDA product code for LPIA-FERRITIN ASSAY?

The FDA product code for LPIA-FERRITIN ASSAY is DEF.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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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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