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FDA 510(k)

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

K-Number: K982251 · 1998-08-18

ApplicantSigma Diagnostics, Inc.
Decision Date1998-08-18
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K982251. 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 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT?

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K982251.

When did SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT received FDA 510(k) clearance on 1998-08-18, under 510(k) number K982251.

Who is the listed applicant for SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT?

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

What is the FDA product code for SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT?

The FDA product code for SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT is CDO.

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Other records listing Sigma Diagnostics, Inc. 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

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.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K955752OLYMPUS URIC ACID REAGENTOlympus 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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