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FDA 510(k)

DATA-ZYME URIC ACID PROCEDURE

K-Number: K831983 · 1983-08-08

ApplicantData Medical Associates, Inc.
Decision Date1983-08-08
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME URIC ACID PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1983-08-08 under 510(k) number K831983. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-ZYME URIC ACID PROCEDURE?

DATA-ZYME URIC ACID PROCEDURE is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K831983.

When did DATA-ZYME URIC ACID PROCEDURE receive FDA 510(k) clearance?

DATA-ZYME URIC ACID PROCEDURE received FDA 510(k) clearance on 1983-08-08, under 510(k) number K831983.

Who is the listed applicant for DATA-ZYME URIC ACID PROCEDURE?

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

What is the FDA product code for DATA-ZYME URIC ACID PROCEDURE?

The FDA product code for DATA-ZYME URIC ACID PROCEDURE is KNK.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

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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