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FDA 510(k)

GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL

K-Number: K851202 · 1985-04-29

ApplicantGilford
Decision Date1985-04-29
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Gilford. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851202. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL?

GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Gilford. The 510(k) number is K851202.

When did GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL receive FDA 510(k) clearance?

GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851202.

Who is the listed applicant for GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL?

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 TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL?

The FDA product code for GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL is DAK.

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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.

K853465GILFORD IMMUNOGLOBULIN G REAGENTK853467GILFORD IMMUNOGLOBULIN A REAGENTK853469GILFORD IMMUNOGLOBULIN M REAGENTK853468GILFORD C4 COMPLEMENT REAGENTK853466GILFORD C3 COMPLEMENT REAGENTK842500DATA MGMT. SYSTEM

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Related Devices (Code: DAK)

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K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, 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.

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