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FDA 510(k)

IN VITRO DIAG. FOR URIC ACID

K-Number: K770767 · 1977-07-05

ApplicantSmithkline Diagnostics, Inc.
Decision Date1977-07-05
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAG. FOR URIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-07-05 under 510(k) number K770767. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAG. FOR URIC ACID?

IN VITRO DIAG. FOR URIC ACID is a medical device that received FDA 510(k) clearance on 1977-07-05. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K770767.

When did IN VITRO DIAG. FOR URIC ACID receive FDA 510(k) clearance?

IN VITRO DIAG. FOR URIC ACID received FDA 510(k) clearance on 1977-07-05, under 510(k) number K770767.

Who is the listed applicant for IN VITRO DIAG. FOR URIC ACID?

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

What is the FDA product code for IN VITRO DIAG. FOR URIC ACID?

The FDA product code for IN VITRO DIAG. FOR URIC ACID is CDO.

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Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, 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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