FDA 510(k)

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105

K-Number: K010421 · 2001-04-13

Decision Date2001-04-13

Product CodeKNK

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K010421. 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 WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105?

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K010421.

When did WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 receive FDA 510(k) clearance?

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 received FDA 510(k) clearance on 2001-04-13, under 510(k) number K010421.

Who is the listed applicant for WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105?

The FDA 510(k) record lists Wiener Laboratories Saic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105?

The FDA product code for WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 is KNK.

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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.