FDA 510(k)

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

K-Number: K940422 · 1994-05-27

Decision Date1994-05-27

Product CodeDFZ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K940422. 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 IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER?

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K940422.

When did IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER receive FDA 510(k) clearance?

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER received FDA 510(k) clearance on 1994-05-27, under 510(k) number K940422.

Who is the listed applicant for IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER?

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

What is the FDA product code for IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER?

The FDA product code for IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER is DFZ.

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Other records listing The Binding Site, Ltd. as applicant

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KIT K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS K081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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Related Devices (Code: DFZ)

K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare Diagnostics K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERThe Binding Site, Ltd.K020823PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITSanquin Blood Supply Foundation K955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.K812821H-103 IGG, H-104 IGA, H-105 IGMImmulok, Inc.K803272AUTOMATED IMMUNOPRECIPITIN METHOD/ICGIcl Scientific

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.