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FDA 510(k)

STATZYME URIC ACID REAGENT

K-Number: K770831 · 1977-07-11

ApplicantWorthington Biochemical Corp.
Decision Date1977-07-11
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATZYME URIC ACID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Biochemical Corp.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K770831. 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 STATZYME URIC ACID REAGENT?

STATZYME URIC ACID REAGENT is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Worthington Biochemical Corp.. The 510(k) number is K770831.

When did STATZYME URIC ACID REAGENT receive FDA 510(k) clearance?

STATZYME URIC ACID REAGENT received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770831.

Who is the listed applicant for STATZYME URIC ACID REAGENT?

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

What is the FDA product code for STATZYME URIC ACID REAGENT?

The FDA product code for STATZYME URIC ACID REAGENT is CDO.

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Other records listing Worthington Biochemical Corp. 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.

K780389HDL REAGENT SET FOR LIPOPROTEINSK780096LDH ISOENZYME CONTROL SERUMK772356LDH ISOENZYME COLUMN REAGENT SETK772025URIC ACID STD. FOR QUANT. URIC ACIDK771001STATZYME GLUCOSEK771143INORGANIC PHOSPHORUS STANDARDS

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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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