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FDA 510(k)

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

K-Number: K020823 · 2002-05-14

ApplicantSanquin Blood Supply Foundation
Decision Date2002-05-14
Product CodeDFZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sanquin Blood Supply Foundation. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K020823. The device is classified under product code DFZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT?

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Sanquin Blood Supply Foundation. The 510(k) number is K020823.

When did PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT receive FDA 510(k) clearance?

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT received FDA 510(k) clearance on 2002-05-14, under 510(k) number K020823.

Who is the listed applicant for PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT?

The FDA 510(k) record lists Sanquin Blood Supply Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT?

The FDA product code for PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT is DFZ.

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Related Devices (Code: DFZ)

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.

K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare DiagnosticsK021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERThe Binding Site, Ltd.K955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERThe Binding Site, Ltd.K812821H-103 IGG, H-104 IGA, H-105 IGMImmulok, Inc.K803272AUTOMATED IMMUNOPRECIPITIN METHOD/ICGIcl Scientific

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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