FDA 510(k)

GILFORD IMMUNOGLOBULIN M REAGENT

K-Number: K853469 · 1985-09-16

Decision Date1985-09-16

Product CodeDFT

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

GILFORD IMMUNOGLOBULIN M REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K853469. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILFORD IMMUNOGLOBULIN M REAGENT?

GILFORD IMMUNOGLOBULIN M REAGENT is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Gilford. The 510(k) number is K853469.

When did GILFORD IMMUNOGLOBULIN M REAGENT receive FDA 510(k) clearance?

GILFORD IMMUNOGLOBULIN M REAGENT received FDA 510(k) clearance on 1985-09-16, under 510(k) number K853469.

Who is the listed applicant for GILFORD IMMUNOGLOBULIN M REAGENT?

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

What is the FDA product code for GILFORD IMMUNOGLOBULIN M REAGENT?

The FDA product code for GILFORD IMMUNOGLOBULIN M REAGENT is DFT.

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Other records listing Gilford as applicant

K853467GILFORD IMMUNOGLOBULIN A REAGENT K853465GILFORD IMMUNOGLOBULIN G REAGENT K853466GILFORD C3 COMPLEMENT REAGENT K853468GILFORD C4 COMPLEMENT REAGENT K851202GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL K842500DATA MGMT. SYSTEM

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Related Devices (Code: DFT)

K983132IGMAbbott Laboratories K962201QUANTEX IGMInstrumentation Laboratory CO K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems Group K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, 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.