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FDA 510(k)

GILFORD C4 COMPLEMENT REAGENT

K-Number: K853468 · 1985-09-16

ApplicantGilford
Decision Date1985-09-16
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GILFORD C4 COMPLEMENT 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 K853468. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILFORD C4 COMPLEMENT REAGENT?

GILFORD C4 COMPLEMENT 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 K853468.

When did GILFORD C4 COMPLEMENT REAGENT receive FDA 510(k) clearance?

GILFORD C4 COMPLEMENT REAGENT received FDA 510(k) clearance on 1985-09-16, under 510(k) number K853468.

Who is the listed applicant for GILFORD C4 COMPLEMENT 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 C4 COMPLEMENT REAGENT?

The FDA product code for GILFORD C4 COMPLEMENT REAGENT is DBI.

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Other records listing Gilford 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.

K853467GILFORD IMMUNOGLOBULIN A REAGENTK853465GILFORD IMMUNOGLOBULIN G REAGENTK853466GILFORD C3 COMPLEMENT REAGENTK853469GILFORD IMMUNOGLOBULIN M REAGENTK851202GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROLK842500DATA MGMT. SYSTEM

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Related Devices (Code: DBI)

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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.

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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