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FDA 510(k)

K-Z CONCENTRATE

K-Number: K781011 · 1978-08-17

ApplicantK-Zyme Labs, Inc.
Decision Date1978-08-17
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

K-Z CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is K-Zyme Labs, Inc.. It received FDA 510(k) clearance on 1978-08-17 under 510(k) number K781011. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-Z CONCENTRATE?

K-Z CONCENTRATE is a medical device that received FDA 510(k) clearance on 1978-08-17. The listed applicant is K-Zyme Labs, Inc.. The 510(k) number is K781011.

When did K-Z CONCENTRATE receive FDA 510(k) clearance?

K-Z CONCENTRATE received FDA 510(k) clearance on 1978-08-17, under 510(k) number K781011.

Who is the listed applicant for K-Z CONCENTRATE?

The FDA 510(k) record lists K-Zyme Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-Z CONCENTRATE?

The FDA product code for K-Z CONCENTRATE is EXB.

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Related Devices (Code: EXB)

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.

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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.

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