FDA 510(k)

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300

K-Number: K012329 · 2001-09-21

Decision Date2001-09-21

Product CodeCIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 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 2001-09-21 under 510(k) number K012329. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300?

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K012329.

When did WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 receive FDA 510(k) clearance?

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012329.

Who is the listed applicant for WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300?

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.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300?

The FDA product code for WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 is CIX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.